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Toxicological information

Eye irritation

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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 guidelineopen allclose all
Qualifier:
according to
Guideline:
other: F.H.S.A 16CFR1500.42
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
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 / 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

Resultsopen allclose all
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
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.