Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1984-09-11 until 1984-09-25
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1981
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Liquid: Clear colourless
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Batch No.of test material: VPS II-ROH T3 (technical grade material)
- Purity test date: 1984-04-03
- Storage condition of test material: in the dark at 22 °C

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: HOECHST AG, Kastengrund
- Weight at study initiation: 3400-4000 g
- Housing: single
- Diet: Altromin 2123 Haltungsdiät - Kaninchen, Altromin-GmbH, (Lage/Lippe, Germany) ad libitum
- Water: deionized, chlorinated water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2
- Humidity (%): 55 +/- 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL
- Concentration: 71%
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
Observations were caried out 1, 24, 48, 72 h and 7 hours after removal of the test substance.
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: with physiological saline solution (37 °C)
- Time after start of exposure: 24 hours

SCORING SYSTEM: According to Draize et al.

TOOL USED TO ASSESS SCORE: fluorescein solution (0.01%)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
> 3 - < 4
Max. score:
4
Reversibility:
not reversible
Remarks:
within 14 days
Irritation parameter:
iris score
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
> 0 - < 1
Max. score:
1
Reversibility:
other: not assessable due to destruction of the complete eyeball
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
> 0
Max. score:
3
Reversibility:
other: not assessable due to whitish discolouration from 1 h onwards
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
> 3 - < 4
Max. score:
4
Reversibility:
not reversible
Remarks:
within 14 days
Irritant / corrosive response data:
From 1 hour after application onwards chemosis was observed, which increased over time in all test animals.
It was not possible to assess the conjunctivae score due to a whitish discolouration of the conjunctivae and nicitating membranes.
Cornea opacity was observed in all treated eyes from 1 hour p.a. onwards, reversibility could not be assessed as in one animal the application led to destruction of the complete eyeball on day 7, in the remaining two animals on day 14.
Discharge was observed in all treated eyes throughout the study period.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
The test item was considered to cause serious eye damage (Category 1).
Executive summary:

The local effect of the test item (technical grade) was investigated according to the method recommended in the OECD Guideline No. 405. Three albino rabbits were exposed to 0.1 mL of the test article, applicated undiluted in one eye. The eyes were examined and the changes were graded according to a numnerical scale one hour, 24, 48 and 72 hours after dosing. Additional examinations were conducted after 7 and 14 days. From 1 hour after application onwards chemosis was observed, which increased over time in all test animals. It was not possible to assess the conjunctivae score due to a whitish discolouration of the conjunctivae and nicitating membranes. Cornea opacity was observed in all treated eyes from 1 hour p.a. onwards, reversibility could not be assessed as in one animal the application led to destruction of the complete eyeball on day 7, in the remaining two animals on day 14. In conclusion the test item causes serious eye damage (Category 1).