Registration Dossier

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:
1993-12-20 to 1994-01-18
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Decanal
EC Number:
203-957-4
EC Name:
Decanal
Cas Number:
112-31-2
Molecular formula:
C10H20O
IUPAC Name:
decanal
Specific details on test material used for the study:
- Name of test material (as cited in study report): Aldehyde C10
- Substance type: Clear liquid
- Physical state: Liquid
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Purity test date: No data
- Batch No: 93/10/02
- Expiration date of the batch: 1994-04
- Stability under test conditions: No data
- Storage condition of test material: Room temperature in the dark

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Froxfield (UK) Ltd, Petersfield, Hampshire, United Kingdom
- Age at study initiation: Approx. 12 to 15 wks
- Weight at study initiation: 2.8 to 3.6 kg
- Housing: Individually in plastic cages with perforated floors
- Diet: SDS Stanrab (P) rabbit diet ad libitum (not analysed)
- Water: Ad libitum
- Acclimation period: Yes, details unclear

ENVIRONMENTAL CONDITIONS
- Temperature: Approx 19 °C
- Humidity: 30 to 70 %
- Air changes: Approx 19 per hr
- Photoperiod: (12 hrs dark / 12 hrs light)

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Volume applied: 0.1 mL
Duration of treatment / exposure:
Single exposure
Observation period (in vivo):
14 d (observations at 1 hr, 24 hr, 48 hr, 72 hr, 4d, 7d, 14 d).
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM:
- Please refer to attached supporting information

TOOL USED TO ASSESS SCORE: hand-held light

CLINICAL SIGNS
- All animals were observed daily for signs of ill health or toxicity.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: Mean of scores at 24, 48 and 72 hours
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: Mean of scores at 24, 48 and 72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: Mean of scores at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: Mean of scores at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: Mean of scores at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: Mean of scores at 24, 48 and 72 h
Score:
0
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
other: Mean of scores at 24 48 and 72 h,
Score:
2
Reversibility:
fully reversible
Remarks:
7 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
other: Mean of scores at 24, 48 and 72 h
Score:
2
Reversibility:
fully reversible
Remarks:
14 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
other: Mean of scores at 24, 48 and 72 h
Score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: Mean of scores at 24, 48 and 72 h
Score:
1.33
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: Mean of scores at 24, 48 and 72 h
Score:
2.33
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: Mean of scores at 24, 48 and 72 h
Score:
2
Reversibility:
fully reversible within: 14 days
Irritant / corrosive response data:
- Dulling of the cornea was seen in 1 animal 1 hr after installation only
- No iridial inflammation was observed
- A diffuse crimson colouration of the conjunctivae was observed in all 3 animals, accompanied by swelling with partial eversion of the eyelids about half closed.
- The eyes were normal 7 or 14 d after instillation
- The results table from the study report is attached as background material.
Other effects:
Clinical signs: There were no signs of toxicity or ill health in any rabbit during the observation period.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
The test substance was assessed for eye irritation according to EU Method B.5. Under the conditions of the test, the test substance caused irritation and should be classified as irritating to eyes (Category 2) according to CLP Regulation No (EC) 1272/2008.