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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
other: 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, my
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