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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Exposure period only 2 hours long. The study was performed in accordance with a recognized scientific procedure for analyzing the primary skin irritation of a test material in experimental animals. The study meets acceptable scientific standards and provides sufficient information to support the conclusion that the test material is a slightly irritating substance to the skin of rabbits.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: According to appraisal of the safety of chemicals in foods, drugs and cosmetics, FDA (Draize) 1959.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Supplier: Röhm GmbH
- Name of test material (as cited in study report): Butylmethacrylat
- Physical state: liquid
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Lot/batch No.: no data

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation:
- Weight at study initiation: 2.5 kg
- Housing: no data
- Diet (e.g. ad libitum): Kaninchenstansartdiät (Höing 222)
- Water (e.g. ad libitum): tap water
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1
- Humidity (%): 50-60
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved or scarified
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
2 hour(s)
Observation period:
immediately and 24 and 48 hours after exposure
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: no data
- Type of wrap if used: occlusive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: no data

SCORING SYSTEM: Draize scale

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean 24+72 h
Score:
0
Max. score:
4
Remarks on result:
other: intact skin, 2 h exposure, observation time 72 h, reevaluation acc. CLP regulation
Irritation parameter:
erythema score
Basis:
animal: # 1, #2, #4 #6
Time point:
other: mean 24+72 h
Score:
0.5
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: intact skin, 2 h exposure, observation time 72 h, reevaluation acc. CLP regulation
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: mean 24+72 h
Score:
1.5
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: intact skin, 2 h exposure, observation time 72 h, reevaluation acc. CLP regulation
Irritation parameter:
edema score
Basis:
animal: #2, #3, #4, #6
Time point:
other: mean 24+72 h
Score:
0
Max. score:
4
Remarks on result:
other: intact skin, 2 h exposure, observation time 72 h, reevaluation acc. CLP regulation
Irritation parameter:
edema score
Basis:
animal #5
Time point:
other: mean 24+72 h
Score:
0.5
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: intact skin, 2 h exposure, observation time 72 h, reevaluation acc. CLP regulation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean 24+72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: intact skin, 2 h exposure, observation time 72 h, reevaluation acc. CLP regulation
Irritation parameter:
erythema score
Remarks:
mean
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
other: mean 24+72 h
Score:
0.583
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: intact skin, 2 h exposure, observation time 72 h, reevaluation acc. DSD (overall mean).
Irritation parameter:
edema score
Remarks:
mean
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
other: mean 24+72 h
Score:
0.25
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: intact skin, 2 h exposure, observation time 72 h, reevaluation acc. DSD (overall mean).

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment