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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
16 May 1991 - 21 May 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Reliability 1 is assigned because the study conducted according to OECD TG 404 and in compliance with GLP, without deviations that influence the quality of the results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
(1981)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Octahydro-4,7-methano-1H-indenecarbaldehyde
EC Number:
250-333-2
EC Name:
Octahydro-4,7-methano-1H-indenecarbaldehyde
Cas Number:
30772-79-3
Molecular formula:
C11H16O
IUPAC Name:
(1R,2S,3S,6R,7S)-tricyclo[5.2.1.0²,⁶]decane-3-carbaldehyde; bis((1R,2S,4R,6R,7S)-tricyclo[5.2.1.0²,⁶]decane-4-carbaldehyde)
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Formyltricyclodecan
- Storage condition of test material: at ambient air temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
- Source: Harald Schriever, Kaninchenfarm, Neuendamm 88, D-2740 Bremervörde
- Weight at study initiation: 2-3 kg
- Housing: Individual housing
- Diet: ad libitum, pellets
- Water: ad libitum, tap water

ENVIRONMENTAL CONDITIONS:
- Temperature (°C): 20±3°C
- Humidity (%): 30-70%
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: contralateral eye of test animals
Amount / concentration applied:
TEST MATERIAL
Amount applied (volume): 0.1 mL
Duration of treatment / exposure:
Single exposure
Observation period (in vivo):
5 days
Number of animals or in vitro replicates:
3
Details on study design:
TREATMENT
The test substance was introduced into the conjunctival sac of the left eye of each animal.

REMOVAL OF TEST SUBSTANCE
- Washing: no

OBSERVATIONS
The eyes of each animal were assessed for ocular reactions 1, 24, 48 and 72 hours after treatment and thereafter once daily up to day 5. Irritation scores and a description of all other (local) effects were recorded.

SCORING SYSTEM
The irritation was assessed according to OECD 405 (1981).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
(opacity)
Basis:
animal #1
Time point:
other: 24, 48 and 72 hrs (mean)
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
cornea opacity score
Remarks:
(opacity)
Basis:
animal #2
Time point:
other: 24, 48 and 72 hrs (mean)
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
cornea opacity score
Remarks:
(opacity)
Basis:
animal #3
Time point:
other: 24, 48 and 72 hrs (mean)
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Time point:
other: 24, 48 and 72 hrs (mean)
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Time point:
other: 24, 48 and 72 hrs (mean)
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Time point:
other: 24, 48 and 72 hrs (mean)
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hrs (mean)
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hrs (mean)
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hrs (mean)
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hrs (mean)
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hrs (mean)
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hrs (mean)
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritant / corrosive response data:
Slight ocular secretion was observed in all animals 1 hour after treatment. In one animal slight alteration of the iris occurred after 1 hour of initiation. Up to 3 days after treatment redness and chemosis of the conjunctivae were observed in all animals. The effects were fully reversible within 4 days.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an eye irritation study with rabbits, performed according to OECD 405, the mean cornea, iris, conjunctivae redness and conjunctivae chemosis scores for all animals were below the limits mentioned in the EU classification criteria. Based on these results, the substance is not considered to be irritating to the eye.
Executive summary:

The substance was tested in an eye irritation test in 3 rabbits in accordance with OECD TG 405 test guideline. Slight ocular secretion was observed in all animals 1 hour after treatment. In one animal slight alteration of the iris occurred after 1 hour of initiation. Up to 3 days after treatment redness and chemosis of the conjunctivae were observed in all animals. The effects were fully reversible within 4 days. The mean cornea, iris, conjunctivae redness and conjunctivae chemosis scores of the 24, 48 and 72 hours reading for all animals were below the limits mentioned in the EU classification criteria (limits being 1, 1, 2 and 2, respectively). Based on these results, the substance is not considered to be irritating to the eye.