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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
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:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) limited
- Age at study initiation: 6 - 8 weeks old
- Weight at study initiation: 197 - 278 g
- Fasting period before study: Not fasted
- Housing: Housed by sex in polypropylene cages with mesh floors suspended over absorbent paper lined trays with a maximum of 5 animals per cage.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days before test commencment


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 21
- Humidity (%): mean of 47
- 12 hour light / dark cycle

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Animals observed for 14 days.
TEST SITE
- Area of exposure: The animals dorsal surface
- % coverage: up to at least 10%
- Type of wrap if used: gauze dressing, encircled with a strip of non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The skin was wiped with a water dampened tissue
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Constant volume or concentration used: yes
Duration of exposure:
24h
Doses:
Dose-range finding study: 400, 1000, 1500, 2000 mg/kg bw
Main Study: 2000mg/kg bw
No. of animals per sex per dose:
Dose-range finding study: 2 males and 2 females per dose group
Main study: 5 males and 5 females per dose group
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Prior to dosing, 7 days after dosing and at the end of day 14.
- Necropsy of survivors performed: yes

Results and discussion

Preliminary study:
In the dose range finding study there were no deaths and no clinical signs or gross post mortem observations.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortalities observed.
Clinical signs:
No Clinical signs observed.
Body weight:
Body weight gains were acceptable.
Gross pathology:
No abnormalities were detected at necropsy.

Applicant's summary and conclusion

Interpretation of results:
other: Low acute toxicity
Conclusions:
LD50 > 2000mg/kg bw in Sprague-Dawley rats under given experimental conditions.