Benzoyl chloride

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: 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

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

Test material information

Constituent 1

Reference substance name:

Benzoyl chloride

EC Number:

202-710-8

EC Name:

Benzoyl chloride

Cas Number:

98-88-4

Molecular formula:

C7H5ClO

IUPAC Name:

benzoyl chloride

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 or test system 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.