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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:
key study
Study period:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted in accordance with accepted test guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: FHSA (CFR 16 1500.41)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Methyl endo-methylene tetrahydro phthalic anhydride
- Analytical purity: Not reported
- Lot/batch No.: Not reported

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Not reported
- Age at study initiation: Not reported
- Weight at study initiation: Not reported
- Housing: Not reported
- Diet (e.g. ad libitum): Not reported
- Water (e.g. ad libitum): Not reported
- Acclimation period: Not reported

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): Not reported

IN-LIFE DATES: July 1980

Test system

Type of coverage:
occlusive
Preparation of test site:
other: Intact and abraded
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

VEHICLE
- Not applicable
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 1 inch x 1 inch square
- Type of wrap if used: Not reported

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not reported

SCORING SYSTEM: Draize scale

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: Intact skin
Remarks:
FHSA test, observations at 24 and 72 hours only
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.5
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: Intact skin
Remarks:
FHSA test, observations at 24 and 72 hours only
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.5
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: Intact skin
Remarks:
FHSA test, observations at 24 and 72 hours only
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2.5
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: Intact skin
Remarks:
FHSA test, observations at 24 and 72 hours only
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: Intact skin
Remarks:
FHSA test, observations at 24 and 72 hours only
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: Intact skin
Remarks:
FHSA test, observations at 24 and 72 hours only
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: Intact skin
Remarks:
FHSA test, observations at 24 and 72 hours only
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: Intact skin
Remarks:
FHSA test, observations at 24 and 72 hours only
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.5
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: Intact skin
Remarks:
FHSA test, observations at 24 and 72 hours only
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: Intact skin
Remarks:
FHSA test, observations at 24 and 72 hours only
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: Intact skin
Remarks:
FHSA test, observations at 24 and 72 hours only
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: Intact skin
Remarks:
FHSA test, observations at 24 and 72 hours only

Any other information on results incl. tables

Animal

Response

24 hours

72 hours

Number

 

Intact

Abraded

Intact

Abraded

1

Erythema

2

2

2

2

 

Oedema

3

3

3

3

2

Erythema

2

2

3

3

 

Oedema

3

3

3

3

3

Erythema

2

2

3

3

 

Oedema

3

3

2

2

4

Erythema

2

2

3

3

 

Oedema

3

3

3

3

5

Erythema

4

2

2

2

 

Oedema

2

3

2

2

6

Erythema

3

3

3

3

 

Oedema

3

3

3

3

 

 

 

 

 

 

Primary Irritation Index:

5.3

Applicant's summary and conclusion

Interpretation of results:
moderately irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The substance is considered to be a moderate to severe irritant
Executive summary:

Skin irritation has been investigated following 24 hours exposure. Well-defined to moderate erythema and slight to moderate oedema was apparent and of sufficient severity for the substance to be regarded as a dermal irritant.