α-chlorotoluene

Eye irritation

Administrative data

Endpoint:

eye 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 acute eye irritation following a methodology similar to the OECD guideline 405 (Acute eye irritation/corrosion) without deviations observed. While GLP standards are not specified, materials and methods as well as results are sufficiently described. Thus, the study should be considered a Klimisch 2c, comparable to a guideline study with acceptable restrictions.

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 16CFR1500.42

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

No data

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

No more data available

Duration of treatment / exposure:

Exposure duration: 24 hours

Observation period (in vivo):

10 days

Number of animals or in vitro replicates:

6

Details on study design:

No data

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

other: 24h

Score:

23.8

Max. score:

110

Reversibility:

fully reversible

Remarks:

10 days

Results 2

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

16.4

Max. score:

23.8

Reversibility:

fully reversible within: 10 days

Irritant / corrosive response data:

- Immediate: discomfort was severe with pawing and eyes tightly closed
- 10 minutes: moderate erythema; copious discharge
- 1 hour: severe erythema; slight edema; copious discharge
- 24 hous: areas of barely perceptible corneal dullness; severe erythema; slight to moderate edema; copious discharge
- 48 to 168 hours: gradual improvement
- 10 days: all scored zero

Other effects:

No data

Any other information on results incl. tables

Table 1: Scores for cornea, iris and conjunctivae after 1h, 24h, 48h, 72h, 120h and 168h for each test organism. For all time point also the mean total

score is given.

Hours	1			24			48			72			120			168
Structure	Cornea	Iris	Conjunctivae	Cornea	Iris	Conjunctivae	Cornea	Iris	Conjunctivae	Cornea	Iris	Conjunctivae	Cornea	Iris	Conjunctivae	Cornea	Iris	Conjunctivae
Animal n° 1	0	0	16	10	0	16	5	0	14	0	0	10	0	0	6	0	0	0
Animal n° 2	0	0	16	5	0	16	0	0	14	0	0	10	0	0	8	0	0	2
Animal n° 3	0	0	16	5	0	16	0	0	12	0	0	8	0	0	4	0	0	0
Animal n° 4	0	0	16	15	0	18	10	0	14	0	0	10	0	0	8	0	0	0
Animal n° 5	0	0	16	5	0	16	0	0	14	0	0	8	0	0	6	0	0	0
Animal n° 6	0	0	16	5	0	16	5	0	14	0	0	6	0	0	4	0	0	0
Mean score (x/110.0)	16.0			23.8			17.0			8.6			6.0			0.3

No further data available

Applicant's summary and conclusion

Interpretation of results:

other: mild irritant

Remarks:

Criteria used for interpretation of results: other: F.H.S.A

Conclusions:

The authors tested acute eye irritation on New Zealand Albino rabbits by benzyl chloride following a methodology similar to the OECD guideline 405 (Acute eye irritation/corrosion). Six rabbits were exposed for 24h to 0.1 mL undiluted benzyl chloride and the effects on the cornea, iris and conjunctivae were recorded at 1, 24, 48, 72, 120, 168 hours and 10 days and graded according to former FHSA criteria. At 24 hours, areas of barely perceptible corneal dullness, severe erythema, slight to moderate edema and copious discharge were observed. From 48 to 168 there was a gradual improvement and after 10 days all scored zero.
Thus benzyl chloride was considered as a mild irritant to eyes according to the FHSA criteria. However, classification according to the CLP regulation n° 1272/2008 EC is not possible.

Executive summary:

The authors tested the acute eye irritation of New Zealand Albino rabbits exposed to benzyl chloride (CAS n° 100-44-7) following a methodology similar to the OECD guideline 405 (Acute eye irritation/corrosion). Six rabbits were exposed for 24h to 0.1 mL undiluted benzyl chloride and the effects on the cornea, iris and conjunctivae were recorded at 1, 24, 48, 72, 120, 168 hours and 10 days, and graded according to FHSA scoring criteria.

Immediately after the exposure, the rabbits exhibited discomfort. The reaction to the test substance increased and the maximum mean total score (i.e. 23.8/110.0) was reached after 24h. At this time point the test specimens displayed areas of barely perceptible corneal dullness, severe erythema, slight to moderate edema and copious discharge. From 48 to 168 there was a gradual improvement and after 10 days all scored zero.

Thus results indicate that benzyl chloride should be considered as a mild irritant according to FHSA criteria. However, benzyl chloride cannot be classified according to the CLP regulation (EC) N° 1272/2008 since the criteria for scoring eye damages are unknown.

While GLP standards are not specified, materials and methods as well as results are sufficiently described. As the study was performed with a methodology similar to the OECD guideline 405 and as no deviations are observed, this study should be considered as reliable with restrictions, a Klimisch 2.c, comparable to a guideline study with acceptable restrictions.