Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
19 Jun 1989 - 26 Jun 1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP - Guideline study, tested with the source substance isooctadecanoic acid (CAS No. 30399-84-9). In accordance to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Prisorine 3505 Acide Isostearique
- Physical state: liquid
- Analytical purity: no data
- Storage condition of test material: at room temperature
- Other: light yellow

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Elevage des Feuilletas
- Weight at study initiation: 2 ± 0.2 kg
- Housing: individually housed in stainless steel cages (61x46x34 cm) with a grid floor
- Diet (ad libitum): UAR 112
- Water (ad libitum): tap water
- Acclimation period: 4 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 5
- Humidity (%): 55 ± 25
- Air changes (per hr): 14
- Photoperiod (hrs dark / hrs light): 12 per day, in a complementary way with natural and artificial lighting

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
single instillation
Observation period (in vivo):
72 h. Reading time points: 1, 24, 48, 72 h
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: Draize scores

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1, 2, 3
Time point:
other: mean over 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: #1, 2, 3
Time point:
other: mean over 24, 48, 72 h
Score:
0
Max. score:
2
Irritation parameter:
chemosis score
Basis:
animal: #1, 2, 3
Time point:
other: mean over 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks:
at 24 h reading
Remarks on result:
other: effects occurred after 1 h
Irritation parameter:
conjunctivae score
Basis:
animal: #1, 2, 3
Time point:
other: mean over 24, 48, 72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible
Remarks:
at 48 h reading
Irritant / corrosive response data:
A slight enanthema together with slight chemosis was observed in all 3 animals at the 1 hour reading. Enanthema remained during 48 hours in one animal and only 24 hours in the other two. Not any lesion of iris or cornea was recorded.

Any other information on results incl. tables

The irritative phenomena were minor and not any lesion was seen after 48 hours.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance does not fulfil the requirements to be classified according to DSD and CLP criteria for classification and labelling.
DSD: no classification
CLP: no classification