Registration Dossier

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

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:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
1980

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Code of Federal Regulations, Title 16, Section 1500.42 Updated as "1500.42 Test for eye irritants" (2009 edition of 16 CFR Ch. II, Consumer Product Safety Commission)
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
α,α,α,4-tetrachlorotoluene
EC Number:
226-009-1
EC Name:
α,α,α,4-tetrachlorotoluene
Cas Number:
5216-25-1
Molecular formula:
C7H4Cl4
IUPAC Name:
1-chloro-4-(trichloromethyl)benzene

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: "Lippischen" test animal brood/Extertal 1
- Weight at study initiation: 2.1 kg
- Housing: individually housed
- Diet (e.g. ad libitum): ad libitum (mümmel z; ssniff/Soest)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 - 14 d
- Sex: male

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 18°C
- Humidity (%): 40%
- Photoperiod (hrs dark / hrs light): 12h light/12h dark

No more data available

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: right eye is used for testing, left eye is control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 µL

No more data available
Duration of treatment / exposure:
No data
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
Six male albino rabbits
Details on study design:
SCORING SYSTEM:
Pathological symptoms were checked in the cornea (i.e. degree of opacity and area of opacity), iris and conjunctivae (i.e. redness, chemosis and "ausflub"). This was done according to a scoring system taken from "The appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, FDA, 1959, p.51). This scoring system is similar to the grading procedure from the OECD guideline 405, except that in the latter opacity is not subdivided and for conjunctiva only redness and chemosis are considered.


TOOL USED TO ASSESS SCORE: The eyes are checked during the test using an ophthalmoscope. After 8 days the cornea is examined after applying fluorescein (1 drop of fluoresceine in opthalmic solution directly on the cornea. After washing with physiological salt water injured areas of the cornea appear yellow green under UV light)


No more data available

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 8 days
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal: 1,2,4,5,6
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal: 3
Time point:
24/48/72 h
Score:
1.66
Max. score:
2
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal: 1,2,5 and 6
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal: 3
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal: 4
Time point:
24/48/72 h
Score:
1.33
Max. score:
2
Reversibility:
not fully reversible within: 8 days
Irritant / corrosive response data:
- Raw data for each individual animal at each observation time is given in the section "Remarks on results including tables and figures"

- Calculation of maximum value:
Cornea: subdivided in degree of opacity and area of opacity, each having a maximum score of 4. The maximum score for the cornea observation equals "degree of opacity" x "area of opacity" x 5 (i.e. maximum score of 80).
Iris: maximum score of 2, which is multiplied by 5. Thus the maximum score for the iris is 10.
Conjunctivae: subdivided in redness, chemosis and "ausflub" which have as maximum score 3, 4 and 3 respectively. The maximum score for the conjunctivae in total equals the sum of the three subdivisions multiplied by 2 (i.e. 20)
Overall irritation score: sum of scores obtained for cornea, iris and conjunctivae. Hence the maximum to be obtained is 110
Other effects:
No data

Any other information on results incl. tables

- The slight irritation has practically disappeared after 8 days.

- Table presenting the raw data of the test:

24h 48h 72h After 8d
N° of test rabbit 1 2 3 4 5 6 1 2 3 4 5 6 1 2 3 4 5 6 1 2 3 4 5 6
Cornea
A) Opacity 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 0 0 0 0 0 0
B) Area 1 1 1 2 1 1 1 1 1 1 1 1 1 1 1 1 1 1 0 0 0 0 0 0
a=AxBx5 (Max. 80) 5 5 5 10 5 5 5 5 5 5 5 5 5 5 5 5 5 5
Iris (A) 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
b=Ax5 (Max. 10) 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Conjunctivae
A) Redness 2 2 1 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 1 1 1 1 1
B) Swelling 2 2 1 2 2 2 2 2 1 1 2 2 2 2 1 1 2 2 2 2 1 1 2 2
C) Ausfluβ 1 1 0 1 1 1 1 1 0 1 2 1 2 1 1 1 2 1 1 0 0 1 0 0
c=(A+B+C)x2(Max. 20) 10 10 4 10 10 10 10 10 6 8 12 10 12 10 8 8 12 10
Sum of a, b and c (Max. 110.0) 15 15 9 20 15 15 15 15 11 13 17 15 17 15 13 13 17 15

- Mean overall irritation score:

sum of individual overall irritation scores divided by 18 (i.e. 6 animals and 3 time points, 24, 48 and 72h). Thus the mean overall irritation score equals 256/18 = 14.7

Applicant's summary and conclusion

Interpretation of results:
other: Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
Eye irritant
Executive summary:

The authors tested eye irritation as a result of exposure to 4-chloro-benzotrichloride (CAS n° 5216-25-1) according to the U.S. Consumer Product Safety Commission, Code of federal regulations, title 16, section 1500.42 (test for eye irritants). The right eye of six white New Zealand Albino rabbits was exposed to the test substance, while the left eye was used as control. Eyes were checked after 24h, 48h and 72h of exposure using a ophthalmoscope. A final check was done after 8 days and slight irritation had practically disappeared.

Under test conditions the substance resulted to be irritant to the eye.