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Diss Factsheets

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted in 1981
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted in 2020
Deviations:
yes
Remarks:
6 animals used instead of 3; no treatment with systemic analgesic or topical anaesthesia of the animals / animal eyes prior, during or after test substance application
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Alcohols, C12-13, branched and linear, ethoxylated
EC Number:
500-457-0
EC Name:
Alcohols, C12-13, branched and linear, ethoxylated
Cas Number:
160901-19-9
Molecular formula:
not applicable; UVCB
IUPAC Name:
Alcohols, C12-13, branched and linear, ethoxylated

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Breeding center Padre Antonio, Italy
- Weight at study initiation: 2 - 3 kg
- Housing: In stainless steel cages type 1472 Tecniplast Gazzada VA, Italy
- Diet: Pelleted complete diet (Nossan, Milano, Italy), ad libitum
- Water: Tap water from the local network, filtered with Seitz filter, ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): at least 8
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
single instillation without washing
Observation period (in vivo):
7 days
Reading time points: 1, 24, 48 and 72 h
Number of animals or in vitro replicates:
6
Details on study design:
SCORING SYSTEM:
Draize Scoring

TOOL USED TO ASSESS SCORE: hand-slit lamp and fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3, #4, #5 and #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritation parameter:
iris score
Basis:
animal: #1, #2, #3, #4, #5 and #6
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility not applicable
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #2 and #4
Time point:
24/48/72 h
Score:
1.67
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal: #3 and #5
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal: #1, #2 and #3
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal: #4, #5 and #6
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritant / corrosive response data:
All animals showed conjunctival redness (scores 1 or 2) and conjunctival chemosis (scores 1 - 2) at the 1 and 24 h reading time point. At the 48 h reading, conjunctival redness (score 1) was observed in all 6 animals and conjunctival chemosis was noted in 3/6 animals. Corneal opacity or iritis findings were not observed at any reading time point. All eye irritation effects were fully reversible within 72 h post test item instillation.

Any other information on results incl. tables

Table 1: Individual scorings

Animal 1 h 24 h 48 h 72 h 7 days Mean 24/48/72 h
Corneal opacity
1 0 0 0 0 0 0.00
2 0 0 0 0 0 0.00
3 0 0 0 0 0 0.00
4 0 0 0 0 0 0.00
5 0 0 0 0 0 0.00
6 0 0 0 0 0 0.00
Iris
1 0 0 0 0 0 0.00
2 0 0 0 0 0 0.00
3 0 0 0 0 0 0.00
4 0 0 0 0 0 0.00
5 0 0 0 0 0 0.00
6 0 0 0 0 0 0.00
Conjunctival redness
1 2 2 1 0 0 1.67
2 2 2 1 0 0 1.67
3 2 1 1 0 0 1.33
4 2 2 1 0 0 1.67
5 2 1 1 0 0 1.33
6 1 1 1 0 0 1.00
Conjunctival chemosis
1 2 1 1 0 0 0.67
2 2 1 1 0 0 0.67
3 1 1 1 0 0 0.67
4 2 1 0 0 0 0.33
5 1 1 0 0 0 0.33
6 1 1 0 0 0 0.33

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
Conclusions:
The test substance did not induce eye irritation in an in vivo study according to OECD guideline 405.