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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: Comparable to guideline study with acceptable restrictions

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Ûberprüfung der durchführbarkeit von Prüfungsvorschriften und der Aussagekraft der Grundprüfung des E. Chem. G
Author:
Korte F and Greim H
Year:
1981
Bibliographic source:
Umweltforschungsplan des Umweltministeriums des Innern, Chemikalien, Forschungsbericht 107 04 006/01. 172
Reference Type:
secondary source
Title:
European Union Risk Assessment Report - 1,2,4-Trichlorobenzene
Author:
European Commission - European Chemicals Bureau
Year:
2003
Bibliographic source:
Office for Official Publications of the European Communities

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
No GLP. Results were not reported in detail. Not all mandatory timepoints are given.
GLP compliance:
no
Remarks:
GLP was not mandatory at the time of the study

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 1,2,4-trichlorobenzene
- Analytical purity: 98%

Test animals / tissue source

Species:
rabbit
Strain:
other: white Russian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.5-2.8 kg
- Housing: animals were individually housed in V2A-Steel cages (floor area 0.4 m²)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 60%± 5%
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light



Test system

Vehicle:
other: no data. The right eye was used as control and was treated with 0.1 mL NaCl isotonic solution
Controls:
other: the right eye was used as control
Amount / concentration applied:
TEST MATERIAL
- Concentration (if solution): 100 mg/ 0.1 mL


Duration of treatment / exposure:
24 hours
Observation period (in vivo):
until 72 hours
Number of animals or in vitro replicates:
6
Details on study design:
Prior to the application and 1, 24, and 72 hours after application, the eyes were ophthalmologic investigated. The eye response was reviewed by 2 independent investigators. In the event of discrepancies in the assessment was the mean value was calculated.

24 hours after application the eye was also treated with fluorescein (Fluorescein Sodium eye solution USP) and then investigated.

The evaluation of the eye response was similar to the Draize scheme:

1) CORNEA Assessment

Opacity
No Opacity 0

Scattered or diffuse 1*
opacities, iris still
clearly visible

Not entirely transparent areas, 2*
details of iris indistinct

Opalescent area, details of 3*
iris not visible,
Size of the pupil difficult to
determine

Opaque, invisible iris 4*


2) IRIS
Normal 0

Abnormal wrinkle formation,
congestion, 1*
swelling, vascular injection,
iris still reacts to light


No reaction to light, haemorrhage, 2*
severe destruction

3) CONJUNCTIVA
Erythema

Normal vessels 0

Hyperaemia 1
Diffuse redness, individual 2*
vessels can not be distinguished


massive redness all sections 3*

Swelling: lids and /or nictitating membrane

No swelling

Light swelling
(inclusive of nictitating membrane) 1

Externally visible swelling with 2*
exstrophy of the lids

Swelling that causes half-close lids 3*

Swelling that causes more then half-close 4*
to complete closed lids

The grades marked with * are considered positive reactions evaluated


Results and discussion

In vivo

Results
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
1
Max. score:
3
Irritant / corrosive response data:
There were no effects on the cornea or iris; test scores for conjunctiva redness and oedema were 1 and 0-2, respectively. 1,2,4-trichlorobenzene resulted in a slight irritation. Fluorescein test was negative.

Any other information on results incl. tables

Detailed test results are not available

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

Korte & Greim (1981)

 

The irritation/ corrosion potential of 1,2,4-trichlorobenzene was investigated with acute irritation/corrosion according to OECD 405 with deviations 1,2,4-TCB (No GLP. Results were not reported in detail), resulted in a slight irritation. There were no effects on the cornea or iris; test scores for conjunctiva redness and oedema were 1 and 0-2, respectively. Detailed test results are not available. 1,2,4-TCB was found to be non-irritating to the eye according to the EU criteria.