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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
Scoring system:Draize Test
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Alcohols, C16-18
EC Number:
267-008-6
EC Name:
Alcohols, C16-18
Cas Number:
67762-27-0
Molecular formula:
C16 H34 O
IUPAC Name:
Alcohols, C16-18
Details on test material:
- Name of test material (as cited in study report):Tradename Alfol 1618 C16-18 alcohols 100% linear

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS: Rabbit
- Strain: New Zealand White
- Sex: not reported
- Source: not reported
- Age: not reported
- Number of animals: 6
- Controls: Untreated eye used as control.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21 degree C
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12 hrs light/12 hrs dark


Test system

Vehicle:
other: peanut oil
Controls:
yes
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
ADMINISTRATION/EXPOSURE
- Preparation of test substance: prepared in vehicle at 40C. The material was a sticky waxy solid and could not be powdered and the melting point was too high to apply without causing heat damage.
- Amount of substance instilled: 0.1 ml
- Vehicle: peanut oil
- Postexposure period: 7 days

EXAMINATIONS
- Scoring system: Draize
- Observation period: 7 days
- Tool used to assess score: not reported.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Conjunctivae (Redness, chemosis, discharge): scored together using the Draize calculation individual scores 4, 4, 2, 4, 0 at 24 hours and 0, 0, 0, 0, 2 at 48 hours.
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48 h
Score:
2.8
Reversibility:
fully reversible
Remarks on result:
other: Mean Draize score at 28 hours 2.8/110
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
48 h
Score:
0.4
Reversibility:
fully reversible
Remarks on result:
other: Mean Draize score at 48 hours 0.4/110.
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Mild redness at 24 hours post instillation in 4 rabbits. Minimal redness in 1 rabbit at 48 hours.
Other effects:
OTHER EFFECTS: One animal died, cause unreported. The remaining animals were scored.

Any other information on results incl. tables

Result:         

 AVERAGE SCORE (24+48+72 hour)

                 - Cornea: 0

                 - Iris: 0

                 - Conjunctivae (Redness, chemosis, discharge): scored togetherusing the Draize calculation individual scores 4, 4, 2, 4, 0 at 24 hours and 0, 0, 0, 0, 2 at 48 hours.

                 - Overall score: Mean Draize score at 28 hours 2.8/110, at 48   hours 0.4/110.

 

                 DESCRIPTION OF LESIONS:

Mild redness at 24 hours post  instillation in 4 rabbits. Minimal redness in 1 rabbit at 48     hours.

 

                REVERSIBILITY: All scores 0 by 72 hours and remaining 0 at day 7.

 

               OTHER EFFECTS: One animal died, cause unreported. The remaining animals were scored.

 

 

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Result: not irritating . Based on the Draize scores reported it is considered that Alcohols, C16-18 is not not an eye irritant according to either EU or GHS criteria.The alcohols with chain lengths of C16-18 are non-irritant to eye.

Executive summary:

Result: not irritating . Based on the Draize scores reported it is considered that Alcohols, C16-18 is not not an eye irritant according to either EU or GHS criteria.The alcohols with chain lengths of C16-18 are non-irritant to eye.