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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Butyl methacrylate
EC Number:
202-615-1
EC Name:
Butyl methacrylate
Cas Number:
97-88-1
Molecular formula:
C8H14O2
IUPAC Name:
butyl methacrylate
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 or test system 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