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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:
23.04.1985 - 07.05.1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
α,2-dichlorotoluene
EC Number:
210-258-8
EC Name:
α,2-dichlorotoluene
Cas Number:
611-19-8
Molecular formula:
C7H6Cl2
IUPAC Name:
1-chloro-2-(chloromethyl)benzene
Details on test material:
Source: HOECHST AG- Code: GLAC 405- Purity: >99%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: HOECHST AG
- Age at study initiation: 3 - 5 months
- Weight at study initiation: 2.1 - 2.5 kg
- Housing: individually
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): 50 +/- 20 %
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of test animal
Amount / concentration applied:
undiluted
Amount applied: 0.1 ml
Duration of treatment / exposure:
24 hour(s)
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
3
Details on study design:
Eyes were rinsed with physiological saline 24 hours after instillation.

Eyes were inspected for integrity before the testing. A solution of fluorescein, sodium salt (0.01%) was dropped into the eye. Then the cornea was investigated using UV radiation 24 hours before application. Afterwards eyes were rinsed.

24 and 72 hours after application eyes were examined for integrity in the same manner.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 hour
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 hours
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48 hours
Score:
1.3
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72 hours
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 7 days
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 14 days
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 hour
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 hours
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 48 hours
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 72 hours
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 7 days
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 14 days
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 hour
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 hours
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 48 hours
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: Animal #2: after 1 hour no opacity was observed. In case of Animal #1 and #3 no opacity was noticed at all.
Other effects:
After 24 hours discharge (clear) was noticed in case of all three treated eyes.

Any other information on results incl. tables

All animals gave positive responses. Beside the numerical
grades of ocular reactions displayed in the table beneath
animals excrete a clear liquid at the day of application.
All symptoms were completely reversible within the observation period.


Numerical grades of ocular reactions after treatment
=====================================================
Animal  Region         Time after application
No.                    ------------------------------
                       1    24   48   72    7    14
                       hr   hr   hr   hr    d    d
-----------------------------------------------------
1       Conjunctivae
        -Chemosis      2    1    0    0     0    0
        -Redness       2    1    1    0     0    0
        Iris           1    0    1    0     0    0
        Cornea         0    0    2    0     0    0
2       Conjunctivae
        -Chemosis      2    2    1    1     1    0
        -Redness       2    3    2    2     2    0
        Iris           1    1    1    0     0    0
        Cornea         0    1    2    0     0    0
3        Conjunctivae
        -Chemosis      2    1    0    0     0    0
        -Redness       2    2    1    0     0    0
        Iris           1    0    1    0     0    0
        Cornea         0    0    2    0     0    0
======================================================

These results have led to the conclusion that OCBC had only
slight eye irritant effects which do not meet criteria for
classification and labelling according to EC regulations.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Due to the result o-Chlorobenzylchloride is not subject to specific labelling under current EU regulations.
Executive summary:

In a primary eye irritation study 0.1 mL of undiluted o-Chlorobenzylchloride (>99 % a.i.) was instilled into the conjunctival sac of the left eye of New Zealand White Rabbits (3 animals) for 24 hours. Eyes were rinsed with physiological saline. The untreated right eye served as control. Animals were observed for 14 days. Observation of the eyes occured 1 h, 24 h, 48 h, 72 h, 7 days and 14 days after application of the test substance. Eye irritation was scored according to OECD GL 405. Conjunctivae showed a diffuse, crimson colour 1 hour after application. On the day of application a moderate circumcorneal hyperaemia of the iris was observed. 24 - 48 hours after application conjunctivae were swelled and showed a colour ranging from diffuse, crimson colour to diffuse beefy red. In one animal signs of opacity were noticed within 24 hours in combination with a swelled conjunctivae showed a diffuse, crimson colour, signs of conjunctivae were seen up to 7 days after application.Development of eye irritation was completely reversible within 14 days. In this study, o-Chlorbenzylchloride exhibited a slight irritating potential.