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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:
from January 1982 to March 1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: standardised study without detailed documentation. Compliance with GLP was not mentioned. Purity of the test substance unknown.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): m-toluylendiamin
no other data

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hacking & Churchill, Ltd. Huntingdon, England
- Age at study initiation: no data
- Weight at study initiation: 3,3-4,9 kg
- Housing: individually in cages
- Diet : ad libitum
- Water : ad libitum
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): ca. 22
- Humidity (%): ca. 60
- Air changes (per hr): no data
- Photoperiod : 12 hrs dark / 12 hrs light


IN-LIFE DATES: no data

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: electric clipped
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg



VEHICLE
- Amount(s) applied (volume or weight with unit): the test substance was moistened with 0.2 ml
Duration of treatment / exposure:
4 jours
Observation period:
skin reaction assessed at 1, 24, 48, 72 hours after exposure
Number of animals:
3 (1 male and 2 females)
Details on study design:
TEST SITE
- Area of exposure: dorsal area of the trunk of the animals (6 cm2)
- % coverage: not precised
- Type of wrap if used: a gauze patch which is held in place with non-irritating tape


REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure: 4 hours


SCORING SYSTEM: similar to the commission Directive 2004/73/EC

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1hr, 24 hr, 48 hr, and 72 hr
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1 hr, 24 hr, 48 hr, and 72 hr
Score:
0
Max. score:
4
Irritant / corrosive response data:
See table 1 in field "remarks on results including tables and figures".
Other effects:
Skin color of the the test site became brown.

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point/ Reversibility Erythema
Max. score: 4
Edema
Max. score: 2
60 min 0/0/0 0/0/0
24h 0/0/0 0/0/0
48 h 0/0/0 0/0/0
72 h 0/0/0 0/0/0
average 24h, 48h, 72h 0 0
Reversibility*)  -  -
Average time (unit) for reversion  -  -

*) Reversibility: c. = completely reversibility; n.c. = not completely reversible; n. = not reversible

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this test, m-Toluylendiamin is not irritating according to the Directive 2004/73/EC and to the EU-GHS, second Revised Edition, 2007.
Executive summary:

In a primary dermal irritation study (Starke B, 1982), adult New Zealand White rabbits (1 male and 2 females) were dermally exposed to 500 mg of m-Toluylendiamine (purity unknown) moistened with 0.2 ml purified water. Test sites were covered with a semi-occlusive dressing for 4 hours. Animals were observed for at least 3 days. The skin reactions were assessed at 1, 24, 48, and 72 hours after removal of the dressing. The mean score was calculated across 3 scoring time, 24, 48, 72 hours after patch removal, for each animal separately.

The test item did not elicit any skin reactions at the application site at any of the observation time except the fact that skin color became brown. Indeed, the individual mean scores for erythema and oedema were 0. Under the conditions of this test, m-Toluylendiamin is not irritating according to the Directive 2004/73/EC and to the EU-GHS, second Revised Edition, 2007.