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Diss Factsheets

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
a)Compound and formulation

TK 11786 was suspended with carboxymethyl-cellulose 2 %. Before treatment the suspension was homogeneously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer.

b)Animals

Healthy random bred rats of the Tif RAIf (SPF) strain raised on our premises were used for these experiments. They were kept at a room temperature of 22 + 1° C, at a relative humidity of 55 + 5 % and on a 14 hours light cycle day. They received ad libitum rat food - NAFAG, Gossau SG - and water. Prior to treatment the animals were adapted to our laboratories for a minimum of 4 days and the initial body weight ranged from 180 to 200 grams. 


c) Treatment* and observations

During the treatment and observation period the rats were housed individually in Macrolon cages (type 2). Approximately 2 4 hours before treatment an area on the back of the rats of approximately 60 square cm was shaved with an electric clipper, For treatment the substance was evenly dispersed on the skin with a syringe and was covered with an occlusive dressing which was fastened around the trunk with an adhesive elastic bandage. After 24 hours the dressing was removed, the skin was cleaned with lukewarm water and the reaction of the skin was appraised.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1-o-tolylbiguanide
EC Number:
202-268-6
EC Name:
1-o-tolylbiguanide
Cas Number:
93-69-6
Molecular formula:
C9H13N5
IUPAC Name:
1-o-tolylbiguanide

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 180-200 g
- Housing: housed individually in metal cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): constant room temperature of 18 +/- 1° C
- Humidity (%): 55 +/- 5 %
- Photoperiod (hrs dark / hrs light): 10 hours dark / 14 hours light

Administration / exposure

Type of coverage:
occlusive
Vehicle:
not specified
Details on dermal exposure:
TEST SITE
- Area of exposure: 60 cm2
- % coverage: ~25%
- Type of wrap if used: covered with an occlusive dressing which was fastened around the trunk with an adhesive elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The dressing was removed and the skin was cleaned with lukewarm water
- Time after start of exposure: After 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2150mg/kg .: ~0.4g // 2780mg/kg .: ~0.5g // 3170 mg/kg .: ~0.6g
- Concentration (if solution): 50%
Duration of exposure:
24 hours
Doses:
single application, 3 concentrations.
2150 mg/kg
2780 mg/kg
3170 mg/kg
No. of animals per sex per dose:
3 male, 3 female per dose.
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: obs. at 1hr , 24hrs , 48 hrs, 7d and 14d.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 3 100 mg/kg bw
Based on:
test mat.
Other findings:
Within 24 hours after treatment the rats in all dosage groups showed dyspnoea, exophthalmus, curved position and ruffled fur. Three to six days after treatment a severe erythema developed into necrosis.
The surviving animals recovered from systemic symptoms within 8 to 13 days. They were submitted to a necropsy whenever they died, survivors on day 14.
No substance related gross organ changes were seen

Any other information on results incl. tables

Dose (mg/kg) Concentration % of formulation Number of Animals Died within
1 hour 24 hours 48 hours 7 days 14 days
2150 50 3 3 0 0 0 0 0 0 0 0 0 0
2780 50 3 3 0 0 0 0 0 0 0 0 0 0
3170 50 3 3 0 0 0 0 0 0 1 0 1 0
No higher doses were possible

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 > 3170mg/kg bw .: not classified under CLP