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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
data is from peer reviewed journals

Data source

Reference
Reference Type:
publication
Title:
Amended Final Report On the Safety Assessment of Pentaerythrityl Rosinate
Author:
F.A. Andersen
Year:
1998
Bibliographic source:
International Journal of Toxicology, Vol 17, Issue 4_suppl, pp. 83 - 94, 1998

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Draize method
Principles of method if other than guideline:
To assess the extent of ocular irritation caused by Pentaerythrityl Rosinate in rabbits according to Draize method
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Resin acids and Rosin acids, esters with pentaerythritol
EC Number:
232-479-9
EC Name:
Resin acids and Rosin acids, esters with pentaerythritol
Cas Number:
8050-26-8
Molecular formula:
C195H288O21
IUPAC Name:
Pentaerythritol ester of rosin
Test material form:
liquid
Details on test material:
Name of the test chemical: Pentaerythritol ester of rosin
Common Name: Pentaerythrityl Rosinate
Molecular Formula: C195H288O21
Substance Type: Organic
Physical State: Liquid
Specific details on test material used for the study:
Name of the test chemical: Pentaerythritol ester of rosin
Common Name: Pentaerythrityl Rosinate
Molecular Formula: C195H288O21
Substance Type: Organic
Physical State: Liquid

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
no data available

Test system

Vehicle:
other: mineral oil
Controls:
not specified
Amount / concentration applied:
10% pentaerythriol rosinate in mineral oil(volume not specified)
Duration of treatment / exposure:
single instillation
Observation period (in vivo):
The treated eyes were examined at 1, 2, 3 days after instillation
Duration of post- treatment incubation (in vitro):
no data available
Number of animals or in vitro replicates:
3
Details on study design:
Area of exposure: conjunctival sac
% coverage: No data
Type of wrap if used: no wrap used

REMOVAL OF TEST SUBSTANCE
Washing (if done): not washed
Time after start of exposure: no data

SCORING SYSTEM:
The reactions were scored at 1, 2, 3 days after instillation according to Draize method. Maximum score = 110

Results and discussion

In vitro

Other effects / acceptance of results:
no data available

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24 h
Score:
2
Max. score:
20
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
2
Max. score:
110
Reversibility:
not specified
Remarks on result:
probability of weak irritation
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
48 h
Score:
1
Max. score:
110
Reversibility:
not specified
Remarks on result:
probability of weak irritation
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
110
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
At day 1, all three rabbits had conjunctival scores of 2/20. The irritation persisted until day 2 in one of the three rabbits. No other signs of irritation were noted. The total and average scores for the test were 2/110 for day 1, 1/110 for day 2, and 0 for day 3.

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
At day 1, all three rabbits had conjunctival scores of 2/20. The irritation persisted until day 2 in one of the three rabbits. No other signs of irritation were noted. The total and average scores for the test were 2/110 for day 1, 1/110 for day 2, and 0 for day 3.
Since the scores were zero and effects were completely resolved by day 3, it can be considered that Pentaerythrityl Rosinate was not irritating to rabbit eyes.
Executive summary:

The extent of ocular irritation caused by Pentaerythrityl Rosinate was assessed in rabbits according to Draize method.10% pentaerythriol rosinate in mineral oil (volume not specified) was instilled in to the conjunctival sac of 3 rabbits. The eyes were not rinsed and no anaesthesia was used throughout the study. The reactions were scored at 1, 2, 3 days after instillation according to Draize method. Maximum score = 110.

At day 1, all three rabbits had conjunctival scores of 2/20. The irritation persisted until day 2 in one of the three rabbits. No other signs of irritation were noted. The total and average scores for the test were 2/110 for day 1, 1/110 for day 2, and 0 for day 3.

Since the scores were zero and effects were completely resolved by day 3, it can be considered that Pentaerythrityl Rosinate was not irritating to rabbit eyes.