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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:
July 5th, 1983 - July 8th, 1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no
Remarks:
but QAU statement included

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- physical state: solid
- Storage condition of test material: in the dark at 20°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 breed
- Weight at study initiation: 3.5 - 3.9 kg
- Housing: individually
- Diet (e.g. ad libitum): Altromin 2013 breedingdiat - rabbit (Altromin GmbH, Lage/Lippe), ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): fully conditioned room
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:
other: polyethylenglycol 400
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg in 0.01 mL polyethylenglycol 400
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with physiological NaCl solution of 37 °C (0.01%)
- Time after start of exposure: 24 hours

SCORING SYSTEM: According to OECD test guideline

TOOL USED TO ASSESS SCORE: magnifier, fluorescein solution (0.01%) and UV light

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: fluorescent test
Basis:
mean
Time point:
other: 24 h - 72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
0
Max. score:
2
Remarks on result:
other: after 1 h of exposure the iris was brownish colored in two of the animals
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
No signs of irritation were observed for the iris and the cornea. After 1 h of exposure the iris was brownish colored in two of the animals. A moderate (grade 1) redness and swelling of the conjunctival sac was observed after 1 h of exposure which both decreased gradually. No swelling was observed from 24 hours onwards and no redness was observed at 72 hours.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was investigated for its potential to be irritant to eyes. All effects observed were fully reversible within 72 h and thus, it was concluded that the test substance is not irritating to eyes.