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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:
not stated
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards with acceptable restrictions

Data source

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

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
TK 11813 was applied to a shaved area of approximately 60 square cm on the backs of rats and the animals were observed until necropsy on day 14
GLP compliance:
no
Remarks:
study predates GLP
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
m-phenylenebis(methylamine)
EC Number:
216-032-5
EC Name:
m-phenylenebis(methylamine)
Cas Number:
1477-55-0
Molecular formula:
C8H12N2
IUPAC Name:
1,3-phenylenedimethanamine
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): TK 11813

Test animals

Species:
rat
Strain:
other: Tif RAIf (SPF) random bred
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Ciba-Geigy, Basle, Switzerland
- Weight at study initiation: 180-200 g
- Housing: Individually in Macrolon cages (type 2)
- Diet: NAFAG, Gossau SG rat food ad libitum
- Water: Ad libitum
- Acclimation period: Minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 1 degrees Centigrade
- Humidity: 55 ± 5 %
- Photoperiod: 14 hours light

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Approximately 24 hours before treatment, an area on the back of the rats of approximately 60 square cm was shaved with an electric clipper. The substance was then evenly dispersed on the skin with a syringe and was covered with an occlusive dressing, which was fastened round the trunk with an adhesive elastic bandage. After 24 hours, the dressing was removed, the skin cleaned with lukewarm water and the reaction of the skin was appraised.
Duration of exposure:
24 hours
Doses:
2150 mg/kg and 3170 mg/kg
No. of animals per sex per dose:
3 males and 3 females
Control animals:
no
Details on study design:
No data
Statistics:
No data

Results and discussion

Preliminary study:
No data
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 3 100 mg/kg bw
Based on:
test mat.
Remarks on result:
other: TK 11813 is described only as a concentrate in the study report and no information is available on the percentage of m-phenylenebis(methylamine)
Mortality:
See Table 1 (below)
Clinical signs:
Within 24 hours after treatment, the rats in both dosage groups showed dyspnoea, curved position and ruffled fur. Five to seven days after treatment, a severe erythema developed into necrosis. The animals recovered from systemic symptoms within 9 to 13 days and underwent necropsy on day 14.
Body weight:
No data
Gross pathology:
No substance related gross organ changes were seen
Other findings:
No data

Any other information on results incl. tables

Table 1 - Rate of deaths

Dose (mg/kg)

Concentration % of formulation

Number of animals

Died within

1 h

24 h

48 h

7 d

14 d

2150

conc

3

3

0

0

0

0

0

0

0

0

0

0

3170

conc

3

3

0

0

0

0

0

0

0

0

0

0

No higher doses were possible

Applicant's summary and conclusion

Conclusions:
The acute LD50 of TK 11813 in rats of both sexes observed over a period of 14 days is greater than 3100 mg/kg. The substance therefore has a slight acute toxicity to the rat by this route of administration.