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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
Study period:
December 1977 till June 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The authors tested the eye irritating potential of benzotrichloride on rabbits according to the method described by the Code of Federal Regulations, Title 16, Section 1500.42. GLP standards are not specified. Although only basic information is provided on the materials and methods, the results are sufficiently described. Hence this study should be considered a klimisch 2b, a guideline study with acceptable restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: ETAD methodology (Code of Federal Regulations, Title 16, Section 1500.42)
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
observation period post exposure only seven days, reversibility not reached
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): benzotrichlorid
- Physical state: colourless, pungent liquid

No more data available

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hacking & Churchill Ltd., Huntingdon, England
- Sex: male and female
- Weight at study initiation: 3 - 4 kg
- Housing: individually caged
- Diet: Rabbit food Z 222 (Fa. Höing, Verden/Aller)
- Water: ad libitum


No more data available

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
After application of the liquid test substance to the eyes, they were not rinsed
Observation period (in vivo):
7d
Number of animals or in vitro replicates:
6
Details on study design:
SCORING SYSTEM: assumed to based on the Code of Federal regulation but not known

No further data

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24h
Score:
0.83
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 48h
Score:
1.67
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 72h
Score:
1.67
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 7d
Score:
0
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
other: all studied time points
Score:
0
Remarks on result:
other: No effect observed
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24h
Score:
4
Reversibility:
not fully reversible within: 7d
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48h
Score:
6
Reversibility:
not fully reversible within: 7d
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72h
Score:
5.67
Reversibility:
not fully reversible within: 7d
Irritant / corrosive response data:
- Cornea: In only two out of six animals an effect was observed. This not very marked opacity of the cornea was restricted to confined areas. At day 7 no effects of treatment with the test substance could be detected in the cornea.
- Iris: No effects were observed.
- Conjunctivae: Effects were not fully reversible within 7 days, with grade 1 redness and/or chemosis persisting in 5 of the 6 animals after 7d.

Any other information on results incl. tables

Table: Overview of toxicological observations to the cornea, iris and conjunctivae after exposure to benzotrichloride (time points 1h, 24h, 48h, 72h and 7d). Calculated values of the irritation score are also given.

N° of test rabbit Toxicological observations Irritation score Sum of irritation scores at 24h, 48h and 72h
Readings Time after application Time after application
1h 24h 48h 72h 7d 24h 48h 72h
1 Cornea Opacity (A) 0 1 1 1 0 5 5 5 15
Area (B) 0 1 1 1 0
Iris (A) 0 0 0 0 0 0 0 0 0
Conjunctivae Redness (A) 1 1 1 1 1 2 4 6 12
Chemosis (B) 1 0 1 1 1

Secretion (C)

1 0 0 1 1
2 Cornea

Opacity (A)

0 0 0 0 0 0 0 0 0
Area (B) 0 0 0 0 0
Iris (A) 0 0 0 0 0 0 0 0 0
Conjunctivae Redness (A) 1 2 2 3 1 6 8 10 24
Chemosis (B) 3 1 1 1 1
Secretion (C) 0 0 1 1 0
3 Cornea Opacity (A) 0 0 1 1 0 0 5 5 10
Area (B) 0 0 1 1 0
Iris (A) 0 0 0 0 0 0 0 0 0
Conjunctivae Redness (A) 2 2 2 2 0 10 12 8 30

Chemosis (B)

1 1 2 1 1
Secretion (C) 1 2 2 1 0
4 Cornea Opacity (A) 0 0 0 0 0 0 0 0 0
Area (B) 0 0 0 0 0
Iris (A) 0 0 0 0 0 0 0 0 0
Conjunctivae Redness (A) 1 1 1 1 0 2 6 4 12
Chemosis (B) 0 0 1 1 1
Secretion (C) 0 0 1 0 0
5 Cornea Opacity (A) 0 0 0 0 0 0 0 0 0

Area (B)

0 0 0 0 0
Iris (A) 0 0 0 0 0 0 0 0 0
Conjunctivae Redness (A) 1 1 1 1 1 2 4 4 10

Chemosis (B)

0 0 0 0 0

Secretion (C)

0 0 1 1 0
6 Cornea Opacity (A) 0 0 0 0 0 0 0 0 0
Area (B) 0 0 0 0 0
Iris (A) 0 0 0 0 0 0 0 0 0
Conjunctivae Redness (A) 1 1 1 1 0 2 2 2 6
Chemosis (B) 0 0 0 0 0
Secretion (C) 0 0 0 0 0

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: Code of Federal Regulations, Title 16
Conclusions:
The authors tested the eye irritation potential of benzotrichloride on rabbits according to the method described by the Code of Federal Regulations, Title 16, Section 1500.42. In the test conditions only two out of the six animals displayed an effect of the test substace in the cornea. In these cases the slight opacity of the cornea was restricted to confined areas after 24h, 48h and 72h. At day 7, effects of treatment with the test substance could no longer be detected in the cornea. The iris did not show any effects of treatment for all test animals at all time points. Finally, the effects observed for the conjunctivae persisted after 7 days in 5 out of 6 animals, thus effects were not fully reversible within 7 days. At this level of information benzotrichloride should be considered as slightly irritating according to the Code of Federal Regulation.
Executive summary:

The authors tested the eye irritation potential of benzotrichloride(CAS n° 98 -07 -7) on rabbits according to the method described by the Code of Federal Regulations, Title 16, Section 1500.42). The eyes of six New Zealand White rabbits (male/female) were exposed to 0.1 mL of test substance. After 1h, 24h, 48h, 72 h and 7 days the eyes were examined and the grade of ocular reactions recorded.

Under the test conditions, only two out of the six animals displayed an effect of the test substace in the cornea. In these cases the slight opacity of the cornea was restricted to confined areas after 24h, 48h and 72h. At day 7, effects of treatment with benzotrichloride could no longer be detected in the cornea. In addition, the iris did not show any effects of treatment for all test animals at all time points. Finally, the effects observed for the conjunctivae persisted after 7 days in 5 out of 6 animals, thus these effects were not fully reversible within 7 days. Hence, at this level of information benzotrichloride is considered slightly irritating according to the Code of Federal Federal Regulation.

GLP standards are not specified. Although only basic information is provided on material and methods, the results are sufficiently described. Hence this study is based on a guideline and no deviations to this methodology are observed, it should therefore be considered as reliable with restrictions, a Klimisch 2.b study, a guideline study with acceptable restrictions.