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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: Guideline and GLP study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988

Materials and methods

Principles of method if other than guideline:
Method: other: according to guideline 84/449/EWG, Amtsblatt der Europaeischen Gemeinschaften Nr. L251 vom 19.09.1984, 103
GLP compliance:
yes
Test type:
other: Acute toxicity: dermal, rat
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1,5-naphthylenediamine
EC Number:
218-817-8
EC Name:
1,5-naphthylenediamine
Cas Number:
2243-62-1
Molecular formula:
C10H10N2
IUPAC Name:
1,5-naphthylenediamine
Details on test material:
Purity 98.4 %

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: Cremophor EL
Duration of exposure:
24 h
Doses:
2000 mg/kg bw.
No. of animals per sex per dose:
5/sex/dose
Control animals:
not specified

Results and discussion

Effect levels
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortalities.
Clinical signs:
No systemic or local symptoms of toxicity were observed.
Body weight:
see: remarks on results
Gross pathology:
No patological-anatomical changes observed

Any other information on results incl. tables

Body weights in (g)

 Animal No: Sex

 Week      

     0  1  2
 1  male  270  286  295
 2 male  263  267  281
 3  male  244  255  276
 4  male  250  285  284
 5 male  240  284  267
 MW  253  275  281
 6  female  199  185  200
 7  female  198  199  205
 8  female  199  214  216
9  female  192  194  190
10  female  198  193  204
  MW    197  197  203

MW= Media

Applicant's summary and conclusion

Executive summary:

In an acute dermal toxicity study 5 male and 5 female Wistar-rats (median weight: 253; 197 g resp.) were treated with 2000 mg/kg of the test substance (in Cremophor EL). The application time was 24h and the observation period 14 days.

No systemic or local symptoms of toxicity were observed.
The LD 50 was > 2000 mg/kg bw.