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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
03 May 1982 to 10 May 1982
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study conducted according to recognised test guideline.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Section 1500.02 Federal Hazardous Substances Act Regulations CFR 16 P.125
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction Products of Diphosphorus Pentaoxide with Alcohols, C14-18 even, salted with Amines, C12-14, Tert-alkyl
EC Number:
943-540-0
Molecular formula:
Too complex
IUPAC Name:
Reaction Products of Diphosphorus Pentaoxide with Alcohols, C14-18 even, salted with Amines, C12-14, Tert-alkyl
Test material form:
not specified
Details on test material:
- Storage condition of test material: room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Housing: Stainless steel caging with elevated wire mesh flooring
- Diet (e.g. ad libitum): wayne 15% Rabbit Ration ad libitum
- Water (e.g. ad libitum): Tap water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 45 +/- 5%
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark

IN-LIFE DATES: From: 03 May 1982 To: 10 may 1982

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The left eye served as a control for each animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml into the right eye per animal
Duration of treatment / exposure:
The test material was not washed from the eye.
Observation period (in vivo):
1, 2, 3, 4, and 7 days
Number of animals or in vitro replicates:
6
Details on study design:
SCORING SYSTEM: Draize scale of scoring ocular lesions

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
animal: 1, 2, 3, 4, 5 and 6
Time point:
other: 1, 2, 3, 4 and 7 d
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal: 1, 2, 3, 4, 5 and 6
Time point:
other: 1, 2, 3, 4 and 7 d
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: 1, 2, 3, 4, 5 and 6
Time point:
other: 1, 2, 3, 4 and 7 d
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal: 1, 2, 3, 4, 5 and 6
Time point:
other: 1, 2, 3, 4 and 7 d
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
No irritation scores greater than zero were recorded for any tissue of any animal.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item is not an irritant to the eye of rabbits. The test material is not classified in accordance with Regulation (EC) No. 1272/2008.
Executive summary:

Test Guidance

In a study conducted according to Section 1500.02 Federal Hazardous Substances Act Regulations CFR 16 P.125 the test chemical was placed into the right eye of each of 6 New Zealand White rabbits. The untreated eye acted as a control. The eyes were not washed after instillation. Treated eyes were examined at 1, 2, 3, 4 and 7 days after instillation.

Results

No irritation score greater than zero was recorded for any tissue of any of the six animals at any of the observation time-points.

Conclusion

The test material is not an irritant to the eye of rabbits. The test material is not classified in accordance with Regulation (EC) No. 1272/2008.