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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions (lack of data on test substance)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
lack of data on test substance
GLP compliance:
yes

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: HRP Inc., Denver, PA, USA
- Age at study initiation: 12 - 13 weeks (female), 16 - 17 weeks (males)
- Weight at study initiation: 2.1 - 2.7 kg
- Housing: animals were housed separately in suspended stainless steel and wire mesh cages with absorbent paper below the cages.
- Diet: Purina Certified Diet 5322 (PMI Feeds Inc., Richmond, IN, USA), the amount of feed was limited on a not further specified daily basis
- Water: tap water, ad libitum
- Acclimation period: 15 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 21
- Humidity (%): 40 - 60
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES:
From: 29 Aug 1995
To: 05 Sep 1995

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: not required, the untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): undiluted
Duration of treatment / exposure:
single application without washing
Observation period (in vivo):
7 d
reading timepoints: 1, 24, 48 and 72 h and 7 d
Number of animals or in vitro replicates:
5 males and 1 female
Details on study design:
SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: 2% sodium fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
24/48/72 h
Score:
0.44
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
One hour after instillation of the test substance, slight conjunctivae redness and chemosis were observed in all animals. After 24 h and 48 h, slight conjunctivae redness was observed in 3 animals. At the 72 h reading timepoint, slight conjunctivae redness was observed in 2 animals. The effect was reversible in all animals within 7 days. The test substance did not affect the other irritation parameters in any animal at any timepoint.
Flurescein staining of the cornea was observed in three animals at the 48 h reading timepoint. At the 72 h reading, no staining of the cornea was observed indicating that the corneal response was superficial and transient.
Other effects:
There were no clinical signs observed in any animal during the study period.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.