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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report which meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Principles of method if other than guideline:
A dose of 0.1 ml of test material was introduced into the lower conjunctival sac of the right eye of each animal. The upper and lower lids were held together for one second prior to releasing to prevent loss of material. The contralateral eye served as the control.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test material was suppplied as a clear liquid.
- Name of test material (as cited in study report): MRD-81-20
- Physical state: clear liquid
- Other: specific gravity 0.954

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Number - 6
- Source: Dutchland Laboratories, Inc.
- Age at study initiation: young adults
- Weight at study initiation: 2.2 - 3.0 kg
- Housing: single
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 21 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22
- Humidity (%): monitored daily
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): used as supplied

Observation period (in vivo):
1, 4, 24, 48 and 72 hours and 4 and 7 days after treatment.
Number of animals or in vitro replicates:
6
Details on study design:
DETAILS
- Material was introduced into the lower conjunctival sac of the right eye of each animal.
- The upper and lower lids were held together for one second prior to releasing to prevent loss of material.
- The contralateral eye served as the control.
SCORING SYSTEM:
- Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: Average 24, 48 and 72 hours
Score:
0.44
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: Average 24, 48 and 72 hours
Score:
0.22
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
iris score
Basis:
mean
Time point:
other: Average 24, 48 and 72 hours
Score:
0
Remarks on result:
other: No effects noted
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: Average 24, 48 and 72 hours
Score:
0
Remarks on result:
other: No effects noted
Irritant / corrosive response data:
Most animals exhibited positive scores for ocular irritation at 1 and 4 hours post exposure. All animals were free of signs of ocular irritation within 48 or 72 hours post instillation of the test material.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Based on observation made at 24, 48, and 72 hours post exposure, this substance is not considered an eye irritant.
Executive summary:

In this study, rabbits were exposed to DTDP to assess eye irritation. A dose of 0.1 ml of test material was introduced into the lower conjunctival sac of the right eye of each animal. The upper and lower lids were held together for one second prior to releasing to prevent loss of material. Assessment of eye irritation occurred at 1, 4, 24, 48 and 72 hours post exposure. Most animals had slight ocular irritation at 1 and 4 hours post exposure. None of the animals exhibited positive scores for ocular irritation at 24 hours, and all animals were free of signs of ocular irritation within 48 or 72 hours post instillation.