α-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: see 'Remark'

Remarks:

The authors tested primary skin irritation with two former guideline of the US CPSC (F.H.S.A 16CFR1500.41) or the US DOT (49CFR173 appendix A) .GLP standards were not specified and only basic data was provided concerning materials and methods. Hence, this study should be considered a Klimisch 2.a, a guideline study without detailled documentation.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: F.H.S.A 16CFR1500.41

Deviations:

not specified

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: D.O.T. 49CFR173 appendix A

Deviations:

not specified

Test guideline 3

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

one experiment time of exposure is 24 hours instead of four hours

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

α-chlorotoluene

EC Number:

202-853-6

EC Name:

α-chlorotoluene

Cas Number:

100-44-7

Molecular formula:

C7H7Cl

IUPAC Name:

(chloromethyl)benzene

Constituent 2

Reference substance name:

chloromethylbenzene

IUPAC Name:

chloromethylbenzene

Details on test material:

- Name of test material (as cited in study report): benzyl chloride

No more data available

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

No data

Test system

Type of coverage:

not specified

Preparation of test site:

not specified

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

Duration of exposure 4h and 24h

Observation period:

14 days at least and 17 days for the 24 hours exposure period

Number of animals:

No clear data but six animals may have been tested

Details on study design:

No data

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 4h

Score:

3

Reversibility:

no data

Remarks on result:

other: exposure of 4h; moderate erythema

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 4h

Score:

3

Reversibility:

no data

Remarks on result:

other: exposure of 4h; moderate edema

Results 3

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24h

Score:

3

Reversibility:

no data

Remarks on result:

other: exposure of 4h; moderate erythema

Results 4

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24h

Score:

3

Reversibility:

no data

Remarks on result:

other: exposure of 4h; moderate edema

Results 5

Irritation parameter:

other: corrosion

Basis:

mean

Time point:

other: 4h, 24h, 48h, 72h and 168h, 14 d and 17 days

Reversibility:

no data

Remarks on result:

other: esposure of 24h; F.H.S.A procedure

Irritant / corrosive response data:

In the 4 hours exposure experiment, the authors observed defatting effects and that the skin sloughed off in ten to fourteen days.Besides, they did not notice in depth injury.
In the 24 hours experiment, the autors observed loosening about edges of scab in fourteen to seventeen days showing injury in depth

Other effects:

No data

Applicant's summary and conclusion

Interpretation of results:

corrosive

Remarks:

Migrated information 24h exposure Criteria used for interpretation of results: other: F.H.S.A.

Conclusions:

The authors tested the primary skin irritation of benzyl chloride with two different methodologies, one described in the F.H.S.A (16CFR1500.41) and one in the D.O.T (49CFR173 appendix A). After 4h of exposure in the D.O.T experiment, the New Zealand rabbits displayed at time points 4h and 24h moderate erythema and edema. In ten to fourteen days a defatting effect was observed, but no injury in depth was observed. The loosening of the edges of scabs after 17 days of exposure to benzyl chloride in the New Zealand rabbits indicated in the F.H.S.A experiment, that the test substance should be classified as corrosive according to F.H.S.A.
Based on the CLP regulation n° 1272/2008 EC, benzyl chloride should be classified as a skin irritant category 2 based on the defatting effect observed in the DOT experiment until the end of observation period (14 days).

Executive summary:

The authors tested the skin irritation properties of benzyl chloride (CAS n° 100-44-7) with two different methodologies, one described in the F.H.S.A (16CFR1500.41) and one in the D.O.T (49CFR173 appendix A). They exposed an unknown number of New Zealand rabbits to 0.5 mL of pure benzyl chloride. Presence of erythema and edema were investigated, besides apparent injury in depth of the skin.

After 4h of exposure in the D.O.T experiment, the New Zealand rabbits displayed at time points 4h and 24h moderate erythema and edema. In ten to fourteen days a defatting effect was observed, but no injury in depth was observed. No reversibility of the observed effects is reported. The loosening of the edges of scabs after 17 days of exposure to benzyl chloride in the New Zealand rabbits indicated in the F.H.S.A experiment, that the test substance should be classified as corrosive according to F.H.S.A. Based on the CLP regulation n° 1272/2008 EC, benzyl chloride should be classified as a skin irritant category 2 based on the defatting effect observed in the DOT experiment until the end of observation period (14 days).

GLP standards were not specified and limited data was given concerning materials and methods as well as results. However, the study was conducted according to two former guideline from the US CPSC (F.H.S.A) and from the US D.O.T (D.O.T). Hence this study should be considered as reliable with restrictions, a Klimisch 2.a, a guideline study without detailled documentation.