Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

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

Constituent 1
Chemical structure
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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
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  3 1  2
 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                                        
 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.

Categories Display