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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
in vivo study performed in 1989
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989
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:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal 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

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Cheshire Rabbit Farms Limited, Duddon Lodge, Tarporley,Cheshire.
- Housing: Housed individually in aluminium cages with grid floors beneath which were peat moss filled trays.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 20 degrees C
- Humidity (%): 49%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): as from supplier, purity not stated
- Applied neat
Duration of treatment / exposure:
The test material (0.5ml) was applied to intact skin on each rabbit under a 2.5 x 2.5 cm patch of gauze. The patch was then covered with micropore tape and the trunk was loosely bound with Elastoplast Elastic bandage which remained in position for 4 hours.
Observation period:
1, 24, 48 and 72h after patch removal.
Number of animals:
3 animals (one male and 2 female)
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: patch of gauze, covered with micropore tape and loosely bound with elastoplast elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with water dampened tissues
- Time after start of exposure: 4 h

SCORING SYSTEM:
OECD recommended scoring system

Results and discussion

In vivo

Results
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 - 24h
Score:
>= 0 - < 2
Max. score:
2
Reversibility:
fully reversible within: 48h
Remarks on result:
other: Grade 2 erythema was noted in two animals after 1h and persisted to 24h in one animal. Grade 1 erythema was nothed in the third animal.
Irritant / corrosive response data:
Well defined erythema was recorded 1 h after patch removal in 2 rabbits and persisted to 24 h in one rabbit, the other improving to show only very slight erythema. Very slight erythema was recorded in the third rabbit, there was no oedema. All sites were normal 48 h after patch removal.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information
Conclusions:
Tolgard TDCP MK1 is irritant to rabbit skin, but this is quickly reversible.