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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation, other
Remarks:
in vivo study performed in 1990
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study generated according to internationally accepted testing guidelines and according to GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Tolgard TDCP MK1
- Physical state: colourless liquid
- Storage condition of test material: In the dark, under ambient conditions
- Analytical purity: not stated

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Cheshire Rabbit Farms Limited, Duddon Lodge, Tarporley, Cheshire.
- Housing: Individually in aluminium cages with grid floor beneath which were peat moss filled trays.
- Diet: ad libitum, standard rabbit diet
- Water: ad libitum
- Acclimation period: 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 15 degrees C
- Humidity (%): 56%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: control eye as only one eye was treated
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): no data
- Approx. 4 hours before test commencement, both eyes of the rabbits were examined and only aniamls with no ocular defects were used in the test.
- The quantity of material instilled into the treated eye was 0.1 ml
- Instillation of the test material was: placing into the right eye by gently pulling the lower lid away from the eyeball to form a sac into which the test material was dropped. The lids were then gently held together for 1 - 2 seconds.
- The left eye remained untreated and served as control.
Duration of treatment / exposure:
Substance was not washed from eye
Observation period (in vivo):
1, 24, 48, 72h after instillation.
Number of animals or in vitro replicates:
3 animals (two male and one female).
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done

SCORING SYSTEM: OECD recommended scoring system

TOOL USED TO ASSESS SCORE: 420/5.5x Panoramic Loupe and pen torch (Pifco).

Results and discussion

In vivo

Results
Irritation parameter:
conjunctivae score
Remarks:
slight conjunctival erythema observed
Basis:
mean
Time point:
other: 1h
Score:
> 0 - <= 1
Max. score:
1
Reversibility:
fully reversible within: 24h
Remarks on result:
other: Conjunctival erythema (score 1) was observed in all 3 animals at 1h, along with slight discharge, all were reversed by 24 h.
Irritant / corrosive response data:
Test substance caused slight erythema, is slightly irritating but under the given experimental conditions would not be considered as corrosive.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information
Conclusions:
Under the given experimental conditions TDCP is slightly irritating, but not corrosive and quickly reversible in New Zealand White rabbits.