Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report equivalent or similar to OECD guideline (405): GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Alkenes, C7-9, hydroformylation products, distn. residues, heavy cracked fraction
EC Number:
308-482-7
EC Name:
Alkenes, C7-9, hydroformylation products, distn. residues, heavy cracked fraction
Cas Number:
98072-31-2
IUPAC Name:
98072-31-2
Details on test material:
- Name of test material (as cited in study report): MRD-85-608
- Physical state: liquid
- Analytical purity: assumed 100 %

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): neat (assumed 100%)
Duration of treatment / exposure:
Single instillation
Observation period (in vivo):
Observations at 1, 4, 24, 48, and 72 hours post-instillation and once per day on days 4 and 7.
Number of animals or in vitro replicates:
6
Details on study design:
SCORING SYSTEM: Driaze

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h
Score:
0.83
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Effects were fully reversible within 4 days in all but one animal
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48 h
Score:
0.83
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Effects were fully reversible within 4 days in all but one animal
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72 h
Score:
0.5
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Effects were fully reversible within 4 days in all but one animal
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 h
Score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 48 h
Score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 72 h
Score:
0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CAS# 98072-31-2 was found to be slightly irritating to the eyes. Effects were reversible within 4 days.
Executive summary:

The ocular irritation potential of CAS# 98072-31-2 was evaluated following a single 0.1 ml instillation to the right eye of 6 rabbits.  The treated eyes of all animals remained unwashed.  Observations for signs of ocular irritation and toxicity were made at 1, 4, 24, 48, and 72 hours post-instillation and once per day on days 4 and 7.  Ocular reactions were graded according to the Draize scale for scoring ocular lesions.  Minimal irritation was observed in the animals; responses were limited to the conjunctiva and included redness, chemosis and discharge.  All effects were fully reversible within 7 days post-instillation.  In all but one animal, all effects were fully reversed within 4 days post-instillation.