3-chloro-p-toluidine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-chloro-p-toluidine

EC Number:

202-446-3

EC Name:

3-chloro-p-toluidine

Cas Number:

95-74-9

Molecular formula:

C7H8ClN

IUPAC Name:

3-chloro-4-methylaniline

Details on test material:

IUCLID4 Test substance: other TS: 3-chloro-p-toluidine (made into a paste with polyethylene glycol); purity: at least 99 %; impurities: max. 1 % p-toluidine

Test animals

Species:

rabbit

Strain:

other: New Zealand

Test system

Type of coverage:

other: patch 2.5*2.5 cm pulp

Preparation of test site:

abraded

Vehicle:

other: polyethylene glycol

Controls:

not specified

Duration of treatment / exposure:

4 hours

Observation period:

The animals were observed after 30 minutes, 60 minutes, 24, 48 and 72 hours after patch removal. Due to the fact that after 72 hours still findings in the skin could be observed, additional observations after 7, 14, and 22 days were performed.

Number of animals:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

1.1

Max. score:

4

Reversibility:

fully reversible within: 14 days

Any other information on results incl. tables

Time after patch removal	30 -60 min			24 hours			48 hours			72 hours			7 days			14 days			22 days
Animal No.	1	2	3	1	2	3	1	2	3	1	2	3	1	2	3	1	2	3	1	2	3
Formation of erythema and eschar	2	2	1	2	1	2	2	2	2	2	3	2	1*	2	1*	0	0	0	0	0	0
Formation of edema	2	2	1	1	0	2	1	2	1	1	1	1	0	1	0	0	0	0	0	0	0
Surface of skin
-dry, rough										x	x	x	x	x	x		x
- fine-flaked														x			x
-coarse-flaked													x		x	x		x
- hardened															x
- parchmenty														x
Skin discolouration
-small surface: light brown					x			x		x	x	x
-large surface: light brown				x			x						x		x

*- thickened, reddish-bluish, circular location (diameter 1 -1.5 cm).

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Executive summary:

In a skin irritation study according to OECD TG 404, 3 hours before starting the experiment, 3 rabbits were depilated in the dorsal area of the torso. Only animals having an intakt skin were used. The test substance (made into a paste with polyethylene glycol) was applied to the skin using a patch. The patch was removed after 4 hours and the skin was washed with lukewarm water.

30 to 60 minutes up to 7 days after patch removal the treated skin of the animals showed marginal observable up to moderate erythema and marginal observable up to slight edema. Swelling was observed and the skin was colored on a small up to large surface, dry, rough, sclerotic and parchmenty. 14 days p.a. no erythema or edema were observed anymore. The skin surface was dry-rough. in 2 rabbits a swelling of skin with and a reddish- bluish colour was abserved. After 22 days all signs were reversible.

According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.