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Toxicological information

Skin irritation / corrosion

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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 guidelineopen allclose all
Qualifier:
according to
Guideline:
other: F.H.S.A 16CFR1500.41
Deviations:
not specified
Qualifier:
according to
Guideline:
other: D.O.T. 49CFR173 appendix A
Deviations:
not specified
Qualifier:
equivalent or similar to
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

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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 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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 4h
Score:
3
Reversibility:
no data
Remarks on result:
other: exposure of 4h; moderate erythema
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 4h
Score:
3
Reversibility:
no data
Remarks on result:
other: exposure of 4h; moderate edema
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24h
Score:
3
Reversibility:
no data
Remarks on result:
other: exposure of 4h; moderate erythema
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24h
Score:
3
Reversibility:
no data
Remarks on result:
other: exposure of 4h; moderate edema
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.