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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented study report, which meets basic scientific principles. Study was conducted prior to GLP and OECD guideline implementation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: internal company guideline similar to OECD 401
Deviations:
no
GLP compliance:
no
Remarks:
before GLP
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
p-phenylenediamine
EC Number:
203-404-7
EC Name:
p-phenylenediamine
Cas Number:
106-50-3
Molecular formula:
C6H8N2
IUPAC Name:
benzene-1,4-diamine
Details on test material:
- Name of test material (as cited in study report): Nako H (p-Phenylenediamin)

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
strain Hoe: WISKf (SPF71), weigth 160-180 g (median 170 g, s= 6,29), only females were used, because pretests didn't show sex-linked differences in sensitivity.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Sesame oil
Doses:
concentration: 1 % solution (1g in 100ml Sesame oil)
Dose: 50 mg/kg bw (1% concentration)
Dose: 80 mg/kg bw (1% concentration)
Dose: 125 mg/kg bw (1% concentration)
Dose: 160 mg/kg bw (1% concentration)
Dose: 200 mg/kg bw (1% concentration)
No. of animals per sex per dose:
10 females per dose
Control animals:
no
Details on study design:
Food was withheld from 16 h prior to 2 h after substance administration. The duration of the observation period was 14 days after administration. Individual weights were determined weekly.
Food: ALTROMIN 1324 from Altromin GmbH in Lage/Lippe, tap water - supply was unrestricted available
Cage: plastic cages with wood shavings
Statistics:
Probit analysis according to Linder and Weber, confidence interval according to Cavallis-Sforza

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
137 mg/kg bw
Based on:
test mat.
Mortality:
During the 14 day observation period lethality was as follows:
at 50 mg/kg bw. 0 of 10
at 80 mg/kg bw. 0 of 10
at 125 mg/kg bw. 3 of 10
at 160 mg/kg bw. 8 of 10
at 200 mg/kg bw.10 of 10
Clinical signs:
Intoxicated animals died between 24 minutes and 24 hours after application.
Symptoms observed: squatting posture, prone position, lateral position, motor excitation, passivity, stupor, disequilibrium, coat bristling, panting, narrow palpebral fissure, mydriasis, tonic convulsions, opistotonus.
Body weight:
Body weight gain without abnormalities.
Gross pathology:
Surviving animals sacrificed at the end of the observation period didn't showed any abnormalities.
Animals that died during observation period revealed: stomach filled with red/brown oily liquid, small intestine filled with white-grey slimy substance

Applicant's summary and conclusion

Interpretation of results:
toxic
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
LD 50: 137 mg/kg bw