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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Study conducted prior to GLP, no guideline followed as none was available in 1982 (OECD 401: 1987). However, the available information is documented sufficiently and allows the conclusion that the study was properly conducted with a scientifically acceptable method.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Code of Federal Regulations, Title 16, Section 1500.41
Deviations:
no
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
p-tert-butylaniline
EC Number:
212-215-9
EC Name:
p-tert-butylaniline
Cas Number:
769-92-6
Molecular formula:
C10H15N
IUPAC Name:
p-tert-butylaniline

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: W. Ostrop / Meerbusch
- Weight at study initiation: 2.7 kg (average)
- Housing: individually in stainless steel cages
- Diet (e.g. ad libitum): "Mümmel Z" (Ssniff, Soest), ad libitum
- Water (e.g. ad libitum): drinking water ad libitum
- Acclimation period: 7-14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-18°C
- Humidity (%): 40%
- Photoperiod (hrs dark / hrs light): 12h dark / 12h light

Test system

Type of coverage:
occlusive
Preparation of test site:
other: both sides clipped, one side also abraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 µL
Duration of treatment / exposure:
24h
Observation period:
8d
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 8x8cm on the back (each side)
- Type of wrap if used: gauze patch (2.5 x 2.5 cm) applied to the skin, held in contact with the skin by indifferent, impermeable PVC film (5x5 cm), fixed by Leukoflex.

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24h

OBSERVATION TIME POINTS: 1, 24, 48, 72h and 8d

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not reversible
Remarks on result:
other: grey-white (24h), later (72h) red-brown, dry leather-like eschar, coming off after 8 days. Starting scarred recovery.
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible

Applicant's summary and conclusion

Interpretation of results:
Category 1 (corrosive) based on GHS criteria
Conclusions:
The study was conducted according to Code of Federal Regulations, Title 16, Section 1500.41 on the registered substance itself. The method is to be considered scientifically reasonable. Hence, the results can be considered as reliable to assess the skin irritating properties of the test substance in rabbits. The primary irritation index was calculated from the individual results, this resulted in mean value of 4 for edema in all tested animals, grey-white (24h), later (72h) red-brown, dry leather-like eschar has been observed, coming off after 8 days (starting scarred recovery) and hence, the substance has to be classified as corrosive to the skin.
Executive summary:

In a skin irritation study ( Code of Federal Regulations, Title 16, Section 1500.41), male rabbits (six animals, New Zealand White) were dermally exposed to 500 µL of test substance for 24 hours. Animals then were observed for 8 days; the primary irritation index was calculated from the results.

This resulted in a primary irritation index of 4 for edema in all tested animals; further, grey-white (24h), later (72h) red-brown, dry leather-like eschar has been observed, coming off after 8 days (starting scarred recovery) and hence, the substance has to be classified as corrosive to the skin.