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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:
key study
Study period:
From January 24 to May 30, 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
individual animal weights not reported; 6 animals tested instead of 3
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Propoxylated neopentylglycol diacrylate
IUPAC Name:
Propoxylated neopentylglycol diacrylate
Constituent 2
Reference substance name:
Reference substance 001
Cas Number:
84170-74-1
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Froxfield (U.K.) Ltd., Petersfield, England
- Age at study initiation: Approximately 12-13 weeks
- Weight at study initiation: 2.8-3.0 kg
- Housing: Housed individually in plastic cages
- Diet: Standard laboratory diet (SDS Stanrab (P) Rabbit diet), ad libitum
- Water: Drinking water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: Approximately 19 °C
- Humidity: 30-70 %
- Air changes: Approximately 19 air changes/h
- Photoperiod: 12 h dark / 12 h artificial light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
No washing was done
Observation period (in vivo):
7 days
- Examination of the eyes was made after 1 h and 1, 2, 3 (equivalent to 24, 48 and 72 h after instillation), 4 and 7 days after instillation.
Number of animals or in vitro replicates:
6 (1 male and 5 females)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: No

SCORING SYSTEM: Draize (1977) scoring system

TOOL USED TO ASSESS SCORE: Observation of the eyes was aided by the use of a handheld light.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
0.45
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Mean individual scores = 0,67 - 0 - 1 - 0 - 0 - 1
Irritation parameter:
iris score
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
0.06
Max. score:
2
Reversibility:
fully reversible within: 4 days
Remarks on result:
other: Mean individual scores = 0 - 0.33 - 0 - 0 - 0 - 0
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
1.34
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Mean individual scores = 1,67 - 1,33 - 2 - 0,67 - 0,66 - 1,67
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
1.11
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Mean individual scores = 1 - 2 - 2 - 0,33- 0,33-1
Irritant / corrosive response data:
- Corneal opacities developed in 3 animals.
- Dulling of the normal lustre of the cornea alone was seen in 2 animals.
- Transient iridial inflammation was observed in 1 animal.
- A diffuse crimson red colouration of the conjunctivae was seen in all 6 animals and was accompanied in 4 by considerable swelling with partial eversion of the eyelids or with the eyelids about half closed.
- Eyes were normal by 3 or 7 days after instillation.
Other effects:
No signs of toxicity were observed in any animal throughout the observation period.

Any other information on results incl. tables

Table 1: Ocular reactions observed after instillation of SR 9003

Rabbit

number

and sex

 

Region of eye

 

1 h

Day after instillation

1

2

3

4

7

020 * (male)

Cornea

 

0

0

1

1

1

0

Iris

 

0

0

0

0

0

0

Conjunctiva

 

Redness

 

2

2

2

1

1

0

Chemosis

 

1

1

1

1

0

0

070 (Female)

Cornea

 

D

0

0

0

0

0

Iris

 

0

0

0

1

0

0

Conjunctiva

 

Redness

 

2

1

1

2

2

0

Chemosis

 

2

2

2

2

1

0

071 (Female)

Cornea

 

D

1

1

1

1

0

Iris

 

0

0

0

0

0

0

Conjunctiva

 

Redness

 

2

2

2

2

2

0

Chemosis

 

2

2

2

2

1

0

553 (Female)

Cornea

 

D

0

0

0

0

0

Iris

 

0

0

0

0

0

0

Conjunctiva

 

Redness

 

2

1

1

0

0

0

Chemosis

 

2

1

0

0

0

0

554 (Female)

Cornea

 

D

0

0

0

0

0

Iris

 

0

0

0

0

0

0

Conjunctiva

 

Redness

 

2

1

1

0

0

0

Chemosis

 

3

1

0

0

0

0

555 (Female)

Cornea

 

D

1

1

1

1

0

Iris

 

0

0

0

0

0

0

Conjunctiva

 

Redness

 

2

2

2

1

1

0

Chemosis

 

1

1

1

1

0

0

 

* Pilot animal

D - Dulling

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
not eye irritating.
Conclusions:
Under the test conditions, Propoxylated neopentylglycol diacrylate is not classified as irritating to eyes.
Executive summary:

In an eye irritation study conducted similarly to the OECD Guideline 405 and in compliance with GLP, 6 healthy rabbits (1 male and 5 females) of the New Zealand White strain were exposed to 0.1 mL of Propoxylated neopentylglycol diacrylate in one eye, while the contralateral eye remained untreated and served as control. The eyelids were then gently held together for one second before releasing. The eyes were examined unwashed and the changes were observed at 1 h and 1, 2, 3 (equivalent to 24, 48 and 72 h), 4 and 7 days after instillation and graded according to the method of Draize (1977). 

Corneal opacification, iridial inflammation and well-defined conjunctival reactions were observed. All reactions had resolved in 3 or 7 days after instillation. Mean individual scores at 24, 48 and 72 h after exposure for the 6 animals were respectively 0.67, 0.00, 1.00, 0.00, 0.00, 1.00 for cornea score; 0.00, 0.33, 0.00, 0.00, 0.00, 0.00 for iris score; 1.67, 1.33, 2.00, 0.67, 0.67, 1.67 for conjunctivae score and 1.00, 2.00, 2.00, 0.33, 0.33, 1.00 for chemosis score. In this study, Propoxylated neopentylglycol diacrylate is not an eye irritant on rabbits.

Under the test conditions, Propoxylated neopentylglycol diacrylate is not classified as irritating to eyes.