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EC number: 928-226-3 | CAS number: 1179884-99-1
- Life Cycle description
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- Endpoint summary
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- Short-term toxicity to fish
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Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was performed between 25 August 2009 and 05 September 2009.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Animals and Animal Husbandry
Two New Zealand White rabbits were supplied by (2030 Teklad Global Rabbit diet supplied by Harlan Teklad, Blackthorn, Bicester, Oxon, UK). At the start of the study the animals weighed 2.06 or 2.19 kg and were twelve to twenty weeks old. After an acclimatisation period of at least five days each animal was given a number unique within the study which was written with a black indelible marker-pen on the inner surface of the ear and on the cage label.
The animals were individually housed in suspended cages. Free access to mains drinking water and food (2030 Teklad Global Rabbit diet supplied by Harlan Teklad, Blackthorn, Bicester, Oxon, UK) was allowed throughout the study. The diet and drinking water were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
The temperature and relative humidity were set to achieve limits of 17 to 23°C and 30 to 70% respectively. Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.
The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study. - Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- water
- Remarks:
- test item was moistened with 0.5 ml of distilled water.
- Controls:
- no
- Amount / concentration applied:
- TEST ITEM
Amount(s) applied: 0.5 g
Concentration: Not applicable.
VEHICLE
Amount(s) applied: 0.5g of test material was moistened with 0.5 ml of distilled water.
Concentration: Not applicable.
Lot/batch no. : Not given in study report. - Duration of treatment / exposure:
- 3 minutes, 1 hour and 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 2
- Details on study design:
- Procedure
On the day before the test each rabbit was clipped free of fur from the dorsal/flank area using veterinary clippers. Only animals with a healthy intact epidermis by gross observation were selected for the study.
One rabbit was initially treated. Three suitable sites were selected on the back of the rabbit. At each test site a quantity of 0.5 g of the test material, moistened with 0.5 ml of distilled water, was introduced under a 2.5 cm x 2.5 cm cotton gauze patch and placed in position on the shorn skin. Each patch was secured in position with a strip of surgical adhesive tape. To prevent the animal interfering with the patches, the trunk of the rabbit was wrapped in an elasticated corset for the duration of the exposure period.
One patch was removed at each of three time points: 3 minutes, 1 hour and 4 hours after application. Any residual test material was removed by gentle swabbing with cotton wool soaked in distilled water.
After consideration of the skin reactions produced in the first animal, an additional animal was treated with 0.5 g of test material moistened with 0.5 ml of distilled water. One patch was applied to the back of the rabbit and was allowed to remain in contact with the skin for a period of four hours.
Immediately following removal of the patches and approximately 1, 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored according to the following scale: - Irritation parameter:
- erythema score
- Basis:
- animal: 68524 male
- Time point:
- other: 0, 1, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no evidence of skin irritation
- Irritation parameter:
- erythema score
- Basis:
- animal: 68543 Male
- Time point:
- other: 0, 1, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No evidence of skin irritation
- Irritation parameter:
- edema score
- Basis:
- animal: 68524 male
- Time point:
- other: 0, 1, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No evidence of skin irritation
- Irritation parameter:
- edema score
- Basis:
- animal: 68543 male
- Time point:
- other: 0, 1, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No evidence of skin irritation
- Irritant / corrosive response data:
- The individual scores for erythema/eschar and oedema are given in remarks on results including tables and figures.
No evidence of skin irritation was noted during the study. - Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: Draize classification scheme
- Conclusions:
- The test material produced a primary irritation index of 0.0 and was classified as NON IRRITANT to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
- Executive summary:
Introduction. The study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method was designed to meet the requirements of the following:
OECD Guidelines for the Testing of Chemicals No. 404 “Acute Dermal Irritation/Corrosion” (adopted 24 April 2002)
Method B4 Acute Toxicity (Skin Irritation) of CommissionRegulation (EC) No. 440/2008
Results. 3-minute and 1-hour semi-occluded applications of the test material to the intact skin of one rabbit producedno evidence of skin irritation.
A single 4-hour, semi-occluded application of the test material to the intact skin of two rabbits produced no evidence of skin irritation.
Conclusion. The test material produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme.
Reference
Skin Reaction |
Observation Time |
Individual Scores - Rabbit Number and Sex |
|
68524Male |
|||
3-Minute Exposure |
1-Hour Exposure |
||
Erythema/Eschar Formation |
Immediately |
0 |
0 |
1 Hour |
0 |
0 |
|
24 Hours |
0 |
0 |
|
48 Hours |
0 |
0 |
|
72 Hours |
0 |
0 |
|
Oedema Formation |
Immediately |
0 |
0 |
1 Hour |
0 |
0 |
|
24 Hours |
0 |
0 |
|
48 Hours |
0 |
0 |
|
72 Hours |
0 |
0 |
Table 2 Individual Skin Reactions Following 4-Hour Exposure
Skin Reaction |
Observation Time |
Individual Scores – Rabbit Number and Sex |
Total |
|
68524Male |
68543Male |
|||
Erythema/Eschar Formation |
Immediately |
0 |
0 |
(0 ) |
1 Hour |
0 |
0 |
( 0 ) |
|
24 Hours |
0 |
0 |
0 |
|
48 Hours |
0 |
0 |
( 0 ) |
|
72 Hours |
0 |
0 |
0 |
|
Oedema Formation |
Immediately |
0 |
0 |
( 0 ) |
1 Hour |
0 |
0 |
( 0 ) |
|
24 Hours |
0 |
0 |
0 |
|
48 Hours |
0 |
0 |
( 0 ) |
|
72 Hours |
0 |
0 |
0 |
|
Sum of 24 and 72-hour Readings (S) : 0 |
||||
Primary Irritation Index (S/4) : 0/4 = 0.0 |
||||
Classification : NON‑IRRITANT |
( ) = Total values not used for calculation of primary irritation index
Table 3 Individual Bodyweights and Bodyweight Changes
Rabbit Number |
Individual Bodyweight (kg) |
Bodyweight Change (kg) |
|
Day 0 |
Day 3 |
||
68524Male |
2.06 |
2.17 |
0.11 |
68543Male |
2.19 |
2.24 |
0.05 |
Interpretation of Results
Calculation of Primary Irritation Index and Grading of Irritancy Potential Using the Draize Scheme
The scores for erythema and oedema at the 24 and 72-hour readings were totalled for the two test rabbits (8 values) and this total was divided by four to give the primary irritation index of the test material. The test material was classified according to the following scheme devised by Draize J H (1959) "Dermal Toxicity" In: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. Association of Food and Drug Officials of theUnited States,Austin,Texas, p.46‑59:
Primary Irritation Index |
Classification of Irritancy |
0 |
Non-irritant |
> 0 to 2 |
Mild irritant |
> 2 to 5 |
Moderate irritant |
> 5 to 8 |
Severe irritant |
If irreversible alteration of the dermal tissue is noted in any rabbit, as judged by the Study Director, which include ulceration and clear necrosis or signs of scar tissue, the test material is classified as corrosive to rabbit skin. Classification according to Draize may, therefore, not be applicable.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was performed between 07 September 2009 and 17 September 2009.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Animals and Animal Husbandry
Two New Zealand White rabbits were supplied by Harlan Laboratories U.K. Ltd, Hillcrest, Belton, Loughborough, UK. At the start of the study the animals weighed 2.34 or 2.63 kg and were twelve to twenty weeks old. After an acclimatisation period of at least five days each animal was given a number unique within the study which was written with a black indelible marker-pen on the inner surface of the ear and on the cage label.
The animals were individually housed in suspended cages. Free access to mains drinking water and food (2030 Teklad Global Rabbit diet supplied by Harlan Teklad, Blackthorn, Bicester, Oxon, UK) was allowed throughout the study. The diet and drinking water were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
The temperature and relative humidity were set to achieve limits of 17 to 23°C and 30 to 70% respectively. Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.
The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study. - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left eye remained untreated and was used for control purposes.
- Amount / concentration applied:
- TEST MATERIAL
Amount(s) applied:
A volume of 0.1 ml of the test material (weighing approximately 60 mg) was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball.
Concentration: used as supplied
VEHICLE
Amount(s) applied:
Not applicable
Concentration:
Not applicable
Lot/batch no. :
Not applicable
Purity:
Not reported - Duration of treatment / exposure:
- 1 hour
- Observation period (in vivo):
- Approximately 1 hour and 24, 48 and 72 hours following treatment
- Number of animals or in vitro replicates:
- 2 animals were tested in total. (After consideration of the ocular responses produced in the first treated animal, one additional animal was treated).
- Details on study design:
- SCORING SYSTEM:
Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment, according to the numerical evaluation given in Appendix 2-see section any other information on materials, (from Draize J H (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC p.48 to 49). - Irritation parameter:
- cornea opacity score
- Basis:
- animal: 68547 Male
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effects observed
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 68562 Male
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effects observed
- Irritation parameter:
- iris score
- Basis:
- animal: 68547 Male
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects observed
- Irritation parameter:
- iris score
- Basis:
- animal: 68562 Male
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects observed
- Irritation parameter:
- other: redness
- Basis:
- animal: 68547 Male
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: score observed at 1 hour
- Irritation parameter:
- other: redness
- Basis:
- animal: 68562 Male
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: score observed at 1 hour
- Irritation parameter:
- chemosis score
- Basis:
- animal: 68547 Male
- Time point:
- other: 1, 24, 48 and 72
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: score observed at 1 hour
- Irritation parameter:
- chemosis score
- Basis:
- animal: 68562Male
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: score observed at 1 hour
- Irritant / corrosive response data:
- Ocular Reactions
Individual and group mean scores for ocular irritation are given in Table 1 and Table 2 (see section any other information on results)
No corneal or iridial effects were noted during the test.
Moderate conjunctival irritation was noted in both treated eyes one hour after treatment with minimal conjunctival irritation noted at the 24-hour observation.
Both treated eyes appeared normal at the 48-hour observation. - Other effects:
- Bodyweight
Individual bodyweights and bodyweight changes are given in Table 3 (see section any other information on results)
Both animals showed expected gain in bodyweight during the study. - Interpretation of results:
- other: minimal irritant
- Remarks:
- Criteria used for interpretation of results: other: modified Kay and Calandra classification system
- Conclusions:
- The test material produced a maximum group mean score of 8.0 and was classified as a minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.
- Executive summary:
Introduction.
The study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method was designed to meet the requirements of the following:
OECD Guidelines for the Testing of Chemicals No. 405 “Acute Eye Irritation/Corrosion” (adopted 24 April 2002)
Method B5 Acute Toxicity (Eye Irritation) of Commission Regulation (EC) No. 440/2008
Result.
A single application of the test material to the non-irrigated eye of two rabbits produced moderate conjunctival irritation. Both treated eyes appeared normal at the 48 hour observation.
Conclusion.
The test material produced a maximum group mean score of 8.0 and was classified as aminimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.
Reference
Interpretation of Results
The numerical values corresponding to each animal, tissue and observation time were recorded. The data relating to the conjunctivae were designated by the letters A (redness), B (chemosis) and C (discharge), those relating to the iris designated by the letter D and those relating to the cornea by the letters E (degree of opacity) and F (area of cornea involved). For each tissue the score was calculated as follows:
Score
for conjunctivae = (A
+ B + C) x 2
Score for iris = D x 5
Score for cornea = (E x F) x 5
Using the numerical data obtained a modified version of the system ( Modified Kay and Calandra Interpretation of Eye Irritation Test was used to classify the ocular irritancy potential of the test material. This was achieved by adding together the scores for the cornea, iris and conjunctivae for each time point for each rabbit. The group means of the total scores for each observation were calculated. The highest of these group means (the maximum group mean score) together with the persistence of the reactions enabled classification of the eye irritancy potential of the test material.
If evidence of irreversible ocular damage is noted, the test material will be classified as corrosive to the eye.
Table 1 Individual Scores and Individual Total Scores for Ocular Irritation
Rabbit Number and Sex |
68547Male |
68562Male |
||||||
IPR= 2 |
IPR = 2 |
|||||||
Time After Treatment |
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
CORNEA |
|
|
|
|
|
|
|
|
E = Degree of Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
F = Area of Cornea Involved |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Score (E x F) x 5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
IRIS |
|
|
|
|
|
|
|
|
D |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Score (D x 5) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
CONJUNCTIVAE |
|
|
|
|
|
|
|
|
A = Redness |
2 |
1 |
0 |
0 |
2 |
1 |
0 |
0 |
B = Chemosis |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
C = Discharge |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
Score (A + B + C) x 2 |
8 |
2 |
0 |
0 |
8 |
2 |
0 |
0 |
Total Score |
8 |
2 |
0 |
0 |
8 |
2 |
0 |
0 |
IPR= Initial pain reaction
Table 2 Individual Total Scores and Group Mean Scores for Ocular Irritation
Rabbit Number and Sex |
Individual Total Scores At: |
|||
1 Hour |
24 Hours |
48 Hours |
72 Hours |
|
68547Male |
8 |
2 |
0 |
0 |
68562Male |
8 |
2 |
0 |
0 |
Group Total |
16 |
4 |
0 |
0 |
Group Mean Score |
8.0 |
2.0 |
0.0 |
0.0 |
Table 3 Individual Bodyweights and Bodyweight Changes
Rabbit Number |
Individual Bodyweight (kg) |
Bodyweight Change (kg) |
|
Day 0 |
Day 3 |
||
68547Male |
2.63 |
2.70 |
0.07 |
68562Male |
2.34 |
2.42 |
0.08 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
A skin irritation study on the isolated registered substance to OECD protocol and to acceptable quality standards showed no signs of irritation meeting the criteria for classification. Similarly an eye irritation study on the isolated registered substance to OECD protocol and to acceptable quality standards showed only transient minimal signs of irritation (probably due to physical irritation) which did not meet the criteria for classification.
Justification for selection of skin irritation / corrosion endpoint:
GLP compliant guideline study with a klimisch score of 1
Justification for selection of eye irritation endpoint:
GLP compliant guideline study with a klimisch score of 1
Justification for classification or non-classification
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.