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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

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
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
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.