4-chlorotoluene

Skin irritation / corrosion

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:

other: in compliance with guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: FDA guideline, Vol 38, no 187 (1973)

Principles of method if other than guideline:

6 rabbits with shaved flancs (each site with intact and scarificed areas) received gauze patches containing 0.5 ml undiluted testsubstance (right flanc) or a 10 % sesame oil solution (left flanc) fixed with a tape and PVC foil (occlussive dressing) for 24 hours. Reading was done immediately after removal of the dressing (24 hour value) and 48 hrs and 72 hrs after start of the experiment. Evaluation of the findings according to Federal Register 38,No.187,1973, § 1500.41

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

4-chlorotoluene

EC Number:

203-397-0

EC Name:

4-chlorotoluene

Cas Number:

106-43-4

Molecular formula:

C7H7Cl

IUPAC Name:

4-chlorotoluene

Details on test material:

p-chlorotoluene (no data on purity)

Test animals

Species:

rabbit

Strain:

Himalayan

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

other: sesame oil

Controls:

not required

Amount / concentration applied:

other: see freetext ME

Duration of treatment / exposure:

24 hour(s)

Observation period:

24, 48, and 72 hours

Number of animals:

6

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24 and 72 hours

Score:

0.21

Max. score:

8

Reversibility:

not fully reversible within: 3 days

Remarks on result:

other: undilited test substance - intact and scarificed skin

Results 2

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24 and 72 hours

Score:

0

Max. score:

8

Reversibility:

not fully reversible within: 2 days

Remarks on result:

other: 10% solution of the test substance - intact and scarificed skin

Other effects:

no data

Any other information on results incl. tables

undiluted testsubstance:
----intact area, reading:
24 hrs: 2/6 with edema, score 1 of max 4; no erythema 
48 hrs: 1/6 with edema, score 1 of max 4; no erythema 
72 hrs: 0/6 with edema; no erythema 
----scarificed area, reading:
24 hrs: 3/6 with edema, score 1 of max 4; no erythema
48 hrs: 0/6 with edema; no erythema 
72 hrs: 0/6 with edema; no erythema 

irritation index (24 and 72 hours): 0.21 of max 8.0

10% sesame oil solution:
-----intact area, reading:
24 hrs: 1/6 with edema, score 1 of max 3, no erythema
48 hrs: 0/6 with edema, no erythema 
72 hrs: 0/6 with edema, no erythema 
-----scarificed area
24 hrs: 0/6 with edema, no erythema 
48 hrs: 0/6 with edema, no erythema 
72 hrs: 0/6 with edema, no erythema 

irritation index (24 and 72 hours): 0.04 of max 8.0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information

Executive summary:

method: 6 rabbits with shaved flancs (each site with intact and scarificed areas) received gauze patches containing 0.5 ml undiluted testsubstance (right flanc) or a 10 % sesame oil solution (left flanc) fixed with a tape and PVC foil (occlussive dressing) for 24 hours. Reading was done immediately after removal of the dressing (24 hour value) and 48 hrs and 72 hrs after start of the experiment. Evaluation of the findings according to Federal Register 38,No.187,1973, § 1500.41

result: not irritating to the skin (intact and scarificed skin)