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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:
31-08-1994 to 22-03-1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
Section 4, sub-section 405, of the OECD Guidelines for Testing of Chemicals (1987)
Deviations:
no
GLP compliance:
yes
Remarks:
GLP equivalent at the time where the conduct of the study was subject to appropriate inspection by the quality assurance unit.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
liquid
Details on test material:
- Lot/batch No.: PPA4800
- Expiration date of the lot/batch: 10-05-2004

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Limited
- Weight at study initiation: 2.80 - 3.59 kg
- Housing: Stainless steel cages mounted in mobile batteries.
- Diet (e.g. ad libitum): Standard pelleted rabbit diet (STANRAB (P) SQC)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18°C (15-23°C)
- Humidity (%): 55% (40%- 70%)

IN-LIFE DATES: From: 04-10-1994 To: 11-10-1994 for the sentinel animal. The remaining two rabbits From: 11-10-1994 To: 14-10-1994

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
Test batch used as is:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL into the left eye
Duration of treatment / exposure:
Each animal was gently restrained. The dose was instilled into the right eye by pulling the lower eylid away from the eyeball to form a cup into which the formulation of the test material was dropped. The eyelids were gently held together for one second and then released. The left eye remained untreated.
Observation period (in vivo):
The eyes were examined at 1, 24, 48 and 72 hours after treatment.
Number of animals or in vitro replicates:
3 rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: Not stated
SCORING SYSTEM: According to the Official Journal of the European Communities.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: 32TD 506M, 432M, 437M
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal: 32TD 506M, 432M, 437M
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal: 32TD 506M, 432M, 437M
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal: 32TD 506M, 437M
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal: 432M
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
Injection of the conjunctival blood vessels and very slight discharge were observed in all the rabbits during the first hour following instillation of the test material. At the 24 hour examination, injection of the conjunctival blood vessels were still apparent in the eye of one rabbit. The eyes of two rabbits were overtly normal at the 24 hour examination and the third at the 48 hour examinations. Instillation of the test material caused a very slight initial pain response in two rabbits and a moderate initial pain response in the third rabbit.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Not classified, Criteria used for interpretation of results: OECD GHS
Conclusions:
Under the conditions of this test and the criteria of the EEC, neutrase was classified as 'non-irritant' to the eye. The formulation had a dry matter content of 23.4% and a total organic solids content of 16.1%.
Executive summary:

The potential of the retail concentration of neutrase PPA 4800, hereafter referred to as neutrase, to cause damage to the conjunctivae, iris or cornea was assessed in three New Zealand white rabbits, each subjected to a single ocular instillation of 0.1 mL of the test material formulation. Ocular reactions were assessed 1, 24, 48 and 72 hours after instillation.

Injection of the conjunctival blood vessels and very slight discharge were observed in all the rabbits during the first hour following instillation. At the 24 hour examination, injection of the conjunctival blood vessels were still apparent in the eye of one rabbit. The eyes of the rabbits were overtly normal at the 24 or 48 hour examinations. Instillation of the test material caused a very slight to moderate initial pain response.

Under the conditions of this test and the criteria of the EEC, neutrase was classified as 'non-irritant' to the eye. The formulation had a dry matter content of 23.4% and a total organic solids content of 16.1%.