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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study performed to Guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Received 30 Novemeber 1988
colourless liquid
stored in dark at ambient temperature
specific gravity 1.29

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River UK LTd, Margate
- Age at study initiation: 6-8 weeks
- Weight at study initiation: 159-274g
- Fasting period before study: none
- Housing: polypropylene cages with mesh floors, max 5 animals per cage
- Diet (e.g. ad libitum): Expanded Rat& Mouse Maintenance Diet ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period:minimum 6 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22C
- Humidity (%): 48%
- Air changes (per hr): not given
- Photoperiod (hrs dark / hrs light ): 12 hr light/dark cycle


IN-LIFE DATES: From: 18 January 1989 To: 9 February 1989

Administration / exposure

Type of coverage:
other: Sleek non-irritating Tape, Smith& Nephew
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure:
- % coverage: upto at least 10%
- Type of wrap if used: Sleek Tape, Smith & Nephew


REMOVAL OF TEST SUBSTANCE
- Washing (if done): water dampened tissue
- Time after start of exposure:24 hrs


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 400, 1000, 1500, 2000 mg/kg
- Concentration (if solution):
- Constant volume or concentration used: no
- For solids, paste formed: yes/no


VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
Duration of exposure:
24 hrs
Doses:
Rangefinding study 400, 1000, 1500, 2000 mg/kg
main study 2000 mg/kg
No. of animals per sex per dose:
2 per sex per dose rangefinding
5 per sex per dose main study
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:daily after exposure, animals weighed prior to dosing, day 7 and day 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight.

Results and discussion

Effect levels
Dose descriptor:
approximate LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
nil
Clinical signs:
no clinical signs noted
Body weight:
bodyweight gains were acceptable
Gross pathology:
nop abnormalities detected.

Any other information on results incl. tables

The median dermal lethal dose (LD50) of Tolgard TMCP in rats is greater than 2000 mg/kg

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The median dermal lethal dose (LD50) of Tolgard TMCP in rats is greater than 2000 mg/kg
Executive summary:

The acute dermal toxicity of Tolgard TMCP was investigated in rats.

A dose rangeing study in pairs of rats indicated that the LD50 value by the dermal route is greater than 2000 mg/kg bw. A main study dose level of 2000 mg/kg bw was selected accordingly.

In the main study, no deaths occured and no clinical signs were noted after 24h dermal administration, under occlusion, of Tolgard TMCP, at a dose level of 2000 mg/kg bw.

The medium Dermal Lethal Dose (LD50) of Tolgard TMCP in rats in this study is greater than 2000 mg/kg bw.