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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1975-10
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
Justification for Read Across is given in Section 13 of IUCLID

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
No indication of the method used to examine ocular reactions. For three of the six rabbits, eyes rinsed after 30 seconds after the test substance application.
Principles of method if other than guideline:
Comparable to OECD 405, without recording of body weight and clinical signs.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: bred on the premises and maintained under a semi-barrier system.
- Age at study initiation: 11-12 weeks
- Weight at study initiation: 2.41 kg (males); 2.24 kg (females)
- Housing: Individually
- Diet: ad libitum, commercial irradiated diet (Styles-Oxoid)
- Water: ad libitum
- Acclimation period: 1 week.

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 1 °C.
- Humidity: 50 - 70 %.
- Photoperiod: 14 hrs dark / 10 hrs light.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated right eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 100 mg
Duration of treatment / exposure:
3 rabbits: eye lid held close for one second, no further washing
3 rabbits: eye lid held close for one second, then flushing with warm water for one minute
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3 rinsed eyes
3 non-rinsed eyes
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: Warm water for 1 minute (3 animals out of 6)
- Time after start of exposure: 30 s

SCORING SYSTEM: Draize Score (cornea scores 0 - 4, iris scores 0 - 2, conjunctiva scores 0-4 for chemosis and 0 - 3 for redness and discharge). Examination after 1h, 6h, 48h and 72h.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 h
Score:
1.6
Max. score:
4
Reversibility:
fully reversible within: 6h
Remarks on result:
other: no chemosis at later observation time points. Results based on animals with non-rinsed eyes.
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 6h and 24h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48h
Remarks on result:
other: No redness observed at later observation time points. Results based on animals with non-rinsed eyes.
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
mean
Time point:
other: 1 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 6 h
Remarks on result:
other: No further discharge observed at later observation time points. Results based on animals with non-rinsed eyes.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1h, 24h, 48h and 72h
Score:
0
Max. score:
4
Remarks on result:
other: Results based on animals with non-rinsed eyes.
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1h, 24h, 48h and 72h
Score:
0
Max. score:
2
Remarks on result:
other: Results based on animals with non-rinsed eyes.
Irritant / corrosive response data:
No indication of eye corrosion observed.
Other effects:
Results are not different if the rinsed eyes are evaluated.

Applicant's summary and conclusion

Interpretation of results:
other: not classified as an eye irritant according to the CLP Regulation (EC) No. 1272/2008
Conclusions:
The substance is considered as a non eye irritant to rabbits.
Executive summary:

The irritation potential of the substance to rabbits was assessed according to a test similar/equivalent to the OECD Guideline 405. 100 mg of the substance was applied in one eye of six New Zealand White rabbits; the untreated eye was used as a control. After 30 seconds of the substance application the eyes of three animals were rinsed with warm water while the remaining three eyes were left unwashed. The eyes were observed for 72 hours and signs in cornea iris and conjunctiva (chemosis, redness, discharge) were scored after 1, 6, 24, 48 and 72 hours.

The mean score (1 -24 -48 -72 hrs) for cornea opacity and iris was 0; mean score (1 h) for conjuctivae chemosis was 1.6 (fully reversible within 6 hrs) and mean score (6 -24 hrs) for conjuctivae redeness was 0.33 (fully reversible within 48 hours). Results are based on non-rinsed eyes but are considered as not being different if the rinsed eyes were evaluated.

The substance is considered as a non eye irritant to rabbits.