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
Study period:
May 3 - 10, 1992
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The eye irritation test, performed in the year 1993, did not follow the OECD. However the conditions applied in the study are acceptable and the result shows that the substance is an eye irritant. Eucarol AGE SS (D-Glucopyranose, oligomeric, 6-(hydrogen 2-sulfobutanedioate), 1- (coco alkyl) ethers, sodium salts ) was used as supporting substance due to the structural analogy. They are both in the category of the long linear and branched chain alcohols. Key points are that the members share the same structural features, similar metabolic pathways, common mode of ecotoxicological action and common levels and mode of human health related effects. Member of the long chain alcohols are of a low order of toxicity following acute and repeated exposures. The overall toxicological profile of the sub-categories of linear and essentially linear alcohols is qualitatively and quantitatively similar for all end points. Reference: OECD SIDS Long chain alcohols, April 18-21, 2006

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: EEC directive 91/325
Principles of method if other than guideline:
Results were interpreted according to the Council Dir. 83/467/EEC adapting for the 50th time Council Dir. 67/548/EEC .
GLP compliance:
no

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: Breeding "Conelli" - Arona, Italy
- Weight at study initiation: 2,5 - 3,5 kg
- Housing: stainless steel cages of mm 450 x 500 x 380 with automatic washing cycle
- Diet (e.g. ad libitum): pellet complete diet
- Water (e.g. ad libitum): filtered water from local network

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2 °C
- Humidity (%): 55% +/- 15%
- Air changes (per hr): at least 25 times per hour
- Photoperiod (hrs dark / hrs light): 12 h/day

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 ml/animal
Observation period (in vivo):
1-24-48 and 72 hours and 7 days from instillation
Number of animals or in vitro replicates:
3 males
Details on study design:
Each animal had an eye treated and the other eye which remained untreated, as a control.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 h
Score:
1
Max. score:
1
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 48 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48 h
Score:
1
Max. score:
1
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 h
Score:
2
Max. score:
2
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 48 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
0

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material, when administered by ocular route to rabbits, in single administration, in according with EEC Dir. 91/325, is to be considered irritant for the eye.