p-tert-butylaniline

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vitro

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Cross-reference

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

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.

Qualifier:

according to guideline

Guideline:

other: Code of Federal Regulations, Title 16, Section 1500.41

Deviations:

no

GLP compliance:

no

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

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

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

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.