Registration Dossier
Registration Dossier
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EC number: 202-723-9 | CAS number: 99-04-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981-05-12
- Deviations:
- yes
- Remarks:
- pH not evaluated, observation after 30-60 min not conducted; Exposure conditions were more intesive than required by the OECD guideline 404 , in respect of duration and coverage. Each animal was treated at clipped intact as well as abraded skin sites.
- Principles of method if other than guideline:
- Exposure conditions were more intensive than required by OECD Guideline 404 such that appliction duration was 24 hours hours instead of 4 hours under, type of coverage was occlusive instead of semiocclusive and each of 6 animals was treated at clipped intact as well as abraded skin sites.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- m-toluic acid
- EC Number:
- 202-723-9
- EC Name:
- m-toluic acid
- Cas Number:
- 99-04-7
- Molecular formula:
- C8H8O2
- IUPAC Name:
- m-toluic acid
- Test material form:
- solid: flakes
- Details on test material:
- - Appearance: light yellow flakes
- Molecular weight: 136.1
- Density: 1.04 g/cm³ (112 °C)
- Flash point: 147 °C
- Boiling point: 263 °C
- Melting point: 111.7 °C
Constituent 1
- Specific details on test material used for the study:
- TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: pulverisation with mortar, moistened with distilled water
Test animals
- Species:
- rabbit
- Strain:
- other: Kbs:JW
- Remarks:
- japanese white rabbit
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kitayama Labes Co., Ltd.
- Weight at study initiation: 2.1 - 2.5 kg
- Diet (ad libitum): solid feed RC-4 (obtained from Oriental Yeast K.K)
- Water ( ad libitum): tap water
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 2 °C
- Humidity (%): 55 ± 6 %
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped, partly left intact, partly abraded (stratum corneum was removed with injection needles)
- Vehicle:
- other: distilled water
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g per application site, clipped intact as well as abraded skin areas were treated at each animal. - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 7 days
- Number of animals:
- 6 male animals
- Details on study design:
- TEST SITE
- Area of exposure: within a circle of 3 cm (according to 7 cm²)
- Type of wrap if used: two layers of gauze patch fixed in a closed patch with Tegaderm (3M) and Ju Picot 5 (obtained from Tokyo Material Research Institute)
REMOVAL OF TEST SUBSTANCE
- removal with gauze soaked in water
OBSERVATION TIME POINTS
- daily after application period. Reported values for 24, 48, 72 and 168 hours
SCORING SYSTEM:
- Method of calculation: scoring of erythema and edema was conducted according to Draize method after 24, 48, 72 and 168 hours.
(Please refer to the field 'Any other information on materials and methods incl. tables')
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact skin; 24 hour occlusive exposure
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact skin; 24 hour occlusive exposure
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact skin; 24 hour occlusive exposure
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact skin; 24 hour occlusive exposure
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact skin; 24 hour occlusive exposure
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact skin; 24 hour occlusive exposure
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: intact skin; 24 hour occlusive exposure
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact skin; 24 hour occlusive exposure
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact skin; 24 hour occlusive exposure
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact skin; 24 hour occlusive exposure
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact skin; 24 hour occlusive exposure
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact skin; 24 hour occlusive exposure
- Other effects:
- no effects observed
Any other information on results incl. tables
Table 1: Results
Items |
Erythema |
Oedema |
||
Observation time |
24 |
72 |
24 |
72 |
Rabbit No. |
|
|
|
|
1 int |
0 |
0 |
0 |
0 |
Abr |
0 |
0 |
0 |
0 |
2 int |
0 |
0 |
0 |
0 |
Abr |
0 |
0 |
0 |
0 |
3 int |
0 |
0 |
0 |
0 |
Abr |
1 |
0 |
0 |
0 |
4 int |
1 |
0 |
0 |
0 |
Abr |
1 |
0 |
0 |
0 |
5 int |
0 |
0 |
0 |
0 |
Abr |
0 |
0 |
0 |
0 |
6 int |
0 |
0 |
0 |
0 |
abr |
0 |
0 |
0 |
0 |
Int: intact skin
Abr: abraded skin
1 out of 6 rabbits displayed at the intact site and 2 out of 6 rabbits displayed at the abraded skin sites mild erythema (Draize score 1) after 24 hours, which was reversible after 48 hours.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance is non-irritating to the skin.
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as skin irritant.
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