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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with well documented report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guidelineopen allclose all
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

Test material

Constituent 1
Details on test material:
- Physical state: Powder
- Lot/batch No.: Mix 51785
- Stability under test conditions: Stable under storage conditions
- Storage condition of test material: At room temperature in the dark

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: Approximately 11 weeks
- Weight at study initiation: 1925-2162 grams
- Housing: individually in cages with perforated floors
- Diet (e.g. ad libitum): Pelleted standard LKK-20 rabbit maintenance diet approximately 100 g per day
- Water (e.g. ad libitum): free access to tap water diluted with decalcified water
- Acclimation period: At least five days under test conditions


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-3C
- Humidity (%): 30-70%
- Air changes (per hr): 7.5-15
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent/ 12 hours dark



IN-LIFE DATES: From: April 5, 1989 To: April 8, 1989

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: moistened with water
Controls:
no
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Observation period:
3 Days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2x3 cm

- Type of wrap if used: Metalline patch mounted to Micropore tape and secured with elastic bandage


REMOVAL OF TEST SUBSTANCE
- Washing (if done): test substance was removed using a dry tissue and subsequently a tissue moistened with tapwater
- Time after start of exposure: Four hours


SCORING SYSTEM:

Erythema and Eschar Formation
No erytehma -0
Very slight erythema (barely perceptible) -1
Well defined erytehma-2
Moderate to sever erythema-3
Severe erytehma (beet redness) to slight eschar formation (injuries in depth)-4

Oedema Formation
No oedema-0
Very slight oedema (barely perceptible)-1
Slight oedema (edes of area well defined by definite raising)-.2
Moderate oedema (raised approximately 1 mm)-3
Severe oedema (raised more than 1 mm and extendign beyond area of expsoure)-4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: average at 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
other:
Time point:
other: na
Score:
0
Remarks on result:
other: non-irritating
Irritant / corrosive response data:
The test material resulted in a primary irritation index of 0 (non-irritating) when applied to the intact rabbit skin. The average (24,48, and 72 hour) eryehtma and edema scores were 0.
Other effects:
Blue staining was observed on the treated skin and on the fur over the head and feet of the animals.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information not classified Criteria used for interpretation of results: EU
Conclusions:
The test material resulted in a primary irritation index of 0 (non-irritating) when applied to the intact rabbit skin. The average (24,48, and 72 hour) erythma and edema scores were 0. The test material is not classifed under EEC Council Directive 67/548/EEC (amended by Directive 83/467/EEC) or by EC 1272/2008.
Executive summary:

Under the conditions of this study, the test material resulted in primary irritation index of 0 (non-irritating) when applied to the intact rabbit skin. The average (24,48, and 72 hour) erythema and edema scores were 0. The test material is not classified under EEC Council Directive 67/548/EEC (amended by Directive 83/467/EEC) or by EC 1272/2008.