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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: 2.c: Comparable to a guideline study with acceptable restrictions. Well described. Only data missing data point at 48 hours, observation period of 72 hours and individual scores not provided.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
missing data point at 48 hours, observation period of 72 hours and individual scores not provided.
GLP compliance:
not specified
Remarks:
Probably not GLP compliant since no GLP standards existed at the time

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): benzoyl chloride
- Physical state: clear liquid
- Lot/batch No.: D11-I40-626
No further details

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2873-3037 grams
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

No further details

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: shaved and half of rabbits shaved and abraded
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
No further details
Duration of treatment / exposure:
4 hours exposure
Observation period:
72 hours
Number of animals:
3 per sex
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes with tepid water
- Time after start of exposure: 4 hours

SCORING SYSTEM: Similar to the OECD system

Results and discussion

In vivo

Results
Irritation parameter:
other: primary irrtation score
Basis:
mean
Time point:
other: 24 hours and 72 hours
Score:
3.8
Reversibility:
no data
Irritant / corrosive response data:
cf table in other information on results
Other effects:
cf table in other information on results
No data

Any other information on results incl. tables

Summation of primary skin observation

Observation Examination interval (number reacting / number dosed) 
Erythema and eschar formation 4 hours 24 hours 72 hours   4 hours 24 hours 72 hours
No erythema 2/3       1/3    
Very slight erythema 1/3 1/3     2/3 1/3  
Well defined erythema   2/3 1/3     2/3 1/3
Moderate to severe erythema     2/3       2/3
Severe erythema              
 

Edema formation

             
No edema 3/3       1/3    
Very slight edema   2/3 1/3   2/3 3/3 3/3
Slight edema   1/3 2/3        
Moderate edema              
Severe edema              
 
Blanching 0/3 1/3 1/3   0/3 2/3 2/3
Atonia 0/3 0/3 1/3   0/3 0/3 0/3
Leathery texture 0/3 0/3 1/3   0/3 0/3 0/3

Applicant's summary and conclusion

Interpretation of results:
moderately irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: Title 49 Transportation , Chapter I, classification of corrosive hazards
Conclusions:
In the test conditions, the authors tested the skin irritant potential of benzoyl chloride on New Zealand rabbits and found the test substance to be moderately irritant to the skin.
According to the classification criteria by the CLP regulation N° 1272/2008 EC and by the DS directive 67/548 EEC, benzoyl chloride cannot be classified based on these data since the individual scores are missing. The results of this study do not support the harmonized classification C;R34 corrosive, causes burns according ATP 31 to 67/548/EC Annex 1 and Skin corr. 1B - H314: Causes severe skin burns and eye dammage according to ATP1 to 1272/2008/EC.
Executive summary:

The authors of this study report tested the skin irritation / corrosion potential of benzoyl chloride (CAS n° 98 -88 -4) on male and female New Zealand albino rabbits weighing initially between 2873 and 3037 grams. They followed a procedure equivalent to the OECD guideline n°404 with minor deviations. Two groups of three rabbits were exposed to 0.5 mL benzoyl chloride for four hours under a semi-occlusive bandage. After the exposure period, the bandage was removed and the test substance was rinsed out with tepid water. Primary skin irritation effects were scored according to OECD criteria (edema & erythema) at patch removal, 24 and 72 hours post exposure. Other corrosive and toxic effects were monitored like blanching, atonia and leathery texture. Reversibility of the observed effects was not checked.

Hence, in the test conditions, all rabbits exhibited signs of low to moderate skin irritation. The overall primary irritation score is reported to be 3.8.

Altogether according the classification criteria by CLP regulation EC n° 1272/2008 and by the DSD directive n° 67/548 EEC, benzoyl chloride cannot be classified as irritant or corrosive to the skin since the individual scores are not available.

The results of this study do not support the harmonized classification 'C;R34 corrosive, causes burns' according ATP 31 to 67/548/EC Annex 1 and 'Skin corr. 1B - H314: Causes severe skin burns and eye dammage' according to ATP1 to 1272/2008/EC.

This study report is well described and based on a good methodology similar to the OECD guideline 404. Minor deviations are observed. Indeed data are lacking on the individual scores, the reversibility of the observed effects is not monitored and the study period is only 72 hours. However, this study report could be considered as reliable with restrictions, a Klimisch 2.c study, comparable to a guideline study with acceptable restrictions.