Registration Dossier
Registration Dossier
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EC number: 202-790-4 | CAS number: 99-82-1
Endpoint summary
Administrative data
Description of key information
The test substance was irritating to the skin of rabbits in a study performed according to the guidelines (Hüls, 1989).
No signs of irritation were observed when the test substance was applied to the rabbit's eye (Hüls 1989)
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:
- 01/03 1989 to 15/03 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: conform the guideline, non-GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: white russian
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Tomae GmbH Biberach
- Sex: male
- Weight at study initiation: 2.2 - 2.4 kg
- Housing: individual
- Diet : K4 Alleindiät für Kaninchen, Ssniff Spezialfütter GmbH Soest, ad libitum
- Water: ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ±1
- Humidity (%): 60 ±5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 01 March 1989 To: 15 March 1989 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 cm3
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- scored at 1, 24, 48 and 72 hours and after 6, 8, 10 and 14 days
- Number of animals:
- 3
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animals 1 - 3
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- other: scabs from day 6 onwards
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animals 1 - 3
- Time point:
- 24 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animals 1 - 3
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- other: scabs from day 8 onwards
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animals 1 - 3
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animals 1 - 3
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- other: scabs from day 8 onwards
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animals 1 - 3
- Time point:
- 72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- not reversible
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- The test substance is considered moderately irritant to the skin
- Executive summary:
Dermal application of the test substance to rabbits resulted in erythema and necrosis after 4 hours exposure. The test substance is considered irritant to the skin.
Reference
| 1h |
| 24 h |
| 48 h |
| 72 h |
| 6 d |
| 8 d |
| 10 d |
| 14 d |
|
| E | O | E | O | E | O | E | O | E | O | E | O | E | O | E | O |
Animal 1 | 3 | 4 | 2 | 4 | 2 | 2 | 2 | 2 | 3* | 3 | scabs | scabs | Loose scabs | |||
Animal 2 | 2 | 4 | 2 | 4 | 2 | 2 | 2 | 2 | 2# | 2 | scabs | scabs | Loose scabs | |||
Animal 3 | 2 | 4 | 2 | 4 | 2 | 2 | 2 | 1 | 3* | 3 | scabs | scabs | Loose scabs | |||
*Redbraun discoloration and dryness of the skin
#Redbraun discoloration of the skin
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (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:
- 01/03 1989 to 07/03 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: conform guideline, non GLP
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: white russian
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Tomae GmbH Biberach
- Sex: male
- Weight at study initiation: 2.4 kg
- Housing: individual
- Diet : K4 Alleindiät für Kaninchen, Ssniff Spezialfütter GmbH Soest, ad libitum
- Water: ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ±1
- Humidity (%): 60 ±5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 01 March 1989 To: 07 March 1989 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 cm3 in the conjunctival sac, washed with physiological saline after 72 h
- Duration of treatment / exposure:
- washed with physiological saline after 72 h
- Observation period (in vivo):
- at 1, 24, 72 h and 6 days after application
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): physiological saline
- Time after start of exposure: after 72 h
SCORING SYSTEM: draize
TOOL USED TO ASSESS SCORE: at the 72 h observation fluorescein was used to assess corneal effects - Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animals 1 - 3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animals 1 - 3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animals 1 - 3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animals 1 - 3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animals 1 - 3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animals 1 - 3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- animals 1 - 3
- Time point:
- 24 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- animals 1 - 3
- Time point:
- 48 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- animals 1 - 3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animals 1 - 3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animals 1 - 3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animals 1 - 3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritant / corrosive response data:
- No irritant effects were observed
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance is not irritating to eyes.
- Executive summary:
In an eye irritation test with rabbits no irritating effects of the test substance became apparent.
Reference
| 1 hour |
| Conjuntivae | 24 hours | Conjuntivae | 48 hours | Conjuntivae | 72 hours | Conjuntivae | 6 days | Conjuntivae | ||||||||||||||
| Cornea | Iris | R | C | D | Cornea | Iris | R | C | D | Cornea | Iris | R | C | D | Cornea | Iris | R | C | D | Cornea | Iris | R | C | D |
Animal 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Animal 2 | 0 | 0 | 2 | 1 | 2 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Animal 3 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for selection of skin irritation / corrosion endpoint:
The test substance was irritant in a study performed according to
the guideline
Justification for selection of eye irritation endpoint:
No effects were observed in a study performed according to the
guideline
Effect level: empty Endpoint conclusion: Adverse effect
observed
Justification for classification or non-classification
The test substance needs to be classified as H315: Causes skin irritation
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.
