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EC number: 246-644-8 | CAS number: 25134-21-8
Skin irritation / corrosion
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:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: FHSA (CFR 16 1500.41)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 1,2,3,6-tetrahydromethyl-3,6-methanophthalic anhydride
- EC Number:
- 246-644-8
- EC Name:
- 1,2,3,6-tetrahydromethyl-3,6-methanophthalic anhydride
- Cas Number:
- 25134-21-8
- Molecular formula:
- C10H10O3
- IUPAC Name:
- 3a,4,7,7a-tetrahydromethyl-4,7-methano-2-benzofuran-1,3-dione
- 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
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system 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.
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