Registration Dossier
Registration Dossier
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EC number: 210-431-8 | CAS number: 615-50-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data provided, not enough details to warrant Klimisch rating 1
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: The Code of Federal Regulations 16 CFR 1500.41 (Method of testing primary irritant substances)
- Deviations:
- yes
- Remarks:
- only three rabbits were used against six as recommended by guideline.
- GLP compliance:
- no
- Remarks:
- pre GLP
Test material
- Reference substance name:
- 2-methyl-p-phenylenediamine
- EC Number:
- 202-442-1
- EC Name:
- 2-methyl-p-phenylenediamine
- Cas Number:
- 95-70-5
- Molecular formula:
- C7H10N2
- IUPAC Name:
- 2-methylbenzene-1,4-diamine
- Reference substance name:
- 2-methyl-1,4-benzenediamine
- IUPAC Name:
- 2-methyl-1,4-benzenediamine
- Details on test material:
- - Name of test material: Toluene-2,5-diamine
- Substance type: Pure active substance
- Physical state: Not reported
- Stability under test conditions: Not available
- Storage condition of test material: Not available
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- Details on test animals & environmental conditions are not provided in the report
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- shaved
- Vehicle:
- water
- Remarks:
- containing 0.05% sodium sulphite (pH 7.0)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5mL
- Concentration: 2.5% w/v
VEHICLE
- Amount(s) applied (volume or weight with unit): Not reported
- Concentration (if solution): Not reported
- Lot/batch no. (if required): Not reported
- Purity: Not reported - Duration of treatment / exposure:
- 24 h
- Observation period:
- Two observation were taken at 24 and 72h from onset of exposure
- Number of animals:
- 3 rabbits
- Details on study design:
- TEST SITE
- Area of exposure: The test material was applied on the intact and abraded skin.
SCORING SYSTEM:
Erythema and eschar reaction
No erythema: 0
Very slight erythema (barely perceptible): 1
Well-defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth): 4
Oedema Formation
No oedema: 0
Very slight oedema (barely perceptible): 1
Slight oedema (edges of area well-defined by definite raising): 2
Moderate oedema (raised approximately 1 mm): 3
Severe oedema (raised more than 1 mm and extending beyond area of exposure): 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Max. score:
- 8
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Remarks:
- combined left (intact) and right (abraded) skin site
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Max. score:
- 8
- Reversibility:
- not specified
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Max. score:
- 8
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Remarks:
- combined left (intact) and right (abraded) skin site
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Max. score:
- 8
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Remarks:
- combined left (intact) and right (abraded) skin site
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Max. score:
- 8
- Reversibility:
- not specified
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Max. score:
- 8
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Remarks:
- combined left (intact) and right (abraded) skin site
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 8
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of weak irritation
- Remarks:
- combined left (intact) and right (abraded) skin site
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 48 h
- Max. score:
- 8
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Max. score:
- 8
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- no indication of irritation
- Remarks:
- combined left (intact) and right (abraded) skin site
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Max. score:
- 8
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Remarks:
- combined left (intact) and right (abraded) skin site
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 48 h
- Max. score:
- 8
- Reversibility:
- not specified
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 72 h
- Max. score:
- 8
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Remarks:
- combined left (intact) and right (abraded) skin site
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Max. score:
- 8
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Remarks:
- combined left (intact) and right (abraded) skin site
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 48 h
- Max. score:
- 8
- Reversibility:
- not specified
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Max. score:
- 8
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Remarks:
- combined left (intact) and right (abraded) skin site
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of weak irritation
- Remarks:
- left (intact) skin site
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Remarks:
- right (abraded) skin site
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 48 h
- Max. score:
- 8
- Reversibility:
- not specified
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- no indication of irritation
- Remarks:
- combined left (intact) and right (abraded) skin site
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.1
- Max. score:
- 16
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- no indication of irritation
- Remarks:
- combined left (intact) and right (abraded) skin site
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.17
- Max. score:
- 16
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- no indication of irritation
- Remarks:
- combined left (intact) and right (abraded) skin site
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 8
- Reversibility:
- fully reversible
- Remarks on result:
- other: (Left) Intact and (right) abraded skin site
- Irritant / corrosive response data:
- - Very slight erythema with and without very slight oedema was observed in the intact and abraded sites of one animal at the 24 h reading.
- Animals did not show any observable response to treatment throughout the 72 h observation period.
- Calculated Primary irritation index (PII): 0.3 - Other effects:
- None
Any other information on results incl. tables
Table 1: Skin irritation potential of toluene-2,5-diamine, 2.5% w/v solution in rabbits (Study # 71167)
Rabbit no. |
Reaction |
24h |
72h |
||
Left intact |
Right abraded |
Left intact |
Right abraded |
||
1 |
Erythema |
0 |
0 |
0 |
0 |
Oedema |
0 |
0 |
0 |
0 |
|
2 |
Erythema |
0 |
0 |
0 |
0 |
Oedema |
0 |
0 |
0 |
0 |
|
3 |
Erythema |
1 |
1 |
0 |
0 |
Oedema |
1 |
0 |
0 |
0 |
|
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: expert judgment
- Conclusions:
- The primary irritation index of Toluene-2,5-diamine, 2.5% w/v solution was calculated to be: 0.3; and was determined to be slightly irritating to rabbit skin.
- Executive summary:
Irritant effects of Toulene-1,5-Diamine on rabbit skin was determined following Method of testing primary irritant substances. The Code of Federal Regulations, Title 16, Section 1500.41
The study was designed to evaluate the irritant effect of Toluene-2,5-diamine to the abraded and intact skin of three albino rabbits, clipped free of hair.
The 2.5% w/v solution of Toulene-2,5-diamine (prepared as aqueous solution containing 0.05% sodium sulphite (pH 7.0)) was applied on (Left) Intact and (right) abraded skin site for the 24-hour period of exposure.
After 24 hours exposure, the patches were removed and observed forerythema and oedema formation. The readings were made at 24h and 72h from onset of exposure.
Very slight erythema with very slight oedema was observed in the intact site of one animal, while very slight oedema was observed at abraded skin site of same animal at the 24 h reading. However, these reactions reversed at 72h reading.
The other two animals did not show any observable response to treatment throughout the 72h of observation period. Therefore it was concluded that the test substance "Toulene-2,5-diamine" is very slightly irritating to rabbit skin.
Based on the above, the primary irritation index of Toluene-2,5-diamine, 2.5% w/v solution was calculated to be 0.3 and was determined to be slightly irritating to rabbit skin
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