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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

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
Justification for type of information:
The study was performed for the notification in other regions where authorities do not accept read-across nor in vitro data.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report date:
2015

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
Guerbet alcohols, C24-26, branched and cyclic
EC Number:
942-520-9
Cas Number:
2041102-78-5
Molecular formula:
not applicable, UVCB
IUPAC Name:
Guerbet alcohols, C24-26, branched and cyclic
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Isofol 2426 S
- Substance type: pure active substance
- Physical state: colourless liquid
- Storage condition of test material: room temperature: 20 ± 5 °C

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: laboratory breed, EUROLAP (F-35140 GOSNE)
- Age at study initiation: 9 or 12 weeks old
- Housing: single housing
- Diet (e.g. ad libitum): SAFE - 112, ad libitum
- Water (e.g. ad libitum): Drinking water ad libitum
- Acclimation period: minimum 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23
- Humidity (%): 30 to 70
- Air changes (per hr): at least 10 per hour
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 ml
Duration of treatment / exposure:
single administration, in each animal the test article was introduced into the conjunctival sac of one eye after gently pulling the lower lid away from the eyeball, afterwards the eyelid was closed for 1 second. The other eye remeined untreated serving as control. Unlimited exposure (not rinsed).
Observation period (in vivo):
1 hour, 24, 48 and 72 hours following treatment.
Number of animals or in vitro replicates:
3 male
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.22
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0.33
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0.33
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Other effects:
none

Any other information on results incl. tables

Table 1: Irritant/corrosive response data at each observation time

Score at time point / Reversibility

 

Cornea

Iris

Conjunctivae Redness

Conjunctiva Chemosis

1 h

0 (3)

0 (3)

1 (3)

1 (2) 0 (1)

24 h

0 (3)

0 (3)

1 (2) 0 (1)

0 (3)
48 h 0 (3) 0 (3) 0 (3) 0 (3)
72 h 0 (3) 0 (3) 0 (3) 0 (3)
 Average 24, 48, 72 h 0 0 0.22 0
 Reversibility * n.a. n. a.  c.  c.

 

* Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible, n.a.= not applicable

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the result of this study, the substance Guerbet alcohols, C24-26, branched and cyclic is not irritating to the eyes.
Executive summary:

An acute eye irritation study was performed in three New Zealand rabboitsa according to OECD tEst Guideline 405. The test item Guerbet alcohols, C24 -26, branched and cyclis was instilled undiluted into the eyes of the rabbits at the dose of 0.1 ml. The ocular reactions observed during the study have been slightl and totally reversible, Based on the result of this study, the substance Guerbet alcohols, C24-26, branched and cyclic is not irritating to the eyes.