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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:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given (Peer reviewed source OECD-SIDS)

Data source

Referenceopen allclose all

Reference Type:
other company data
Title:
Unnamed
Year:
1973
Reference Type:
secondary source
Title:
p-Toluidine - CAS No: 106-49-0 - SIDS Initial Assessment Report.
Author:
OECD
Year:
2005
Bibliographic source:
UNEP Publications

Materials and methods

Principles of method if other than guideline:
Dermal application of 464 - 1470 mg/kg bw moistened p-toluidine (exposure time not mentioned) to 5 rabbits/dose group
GLP compliance:
no
Remarks:
GLP was not mandatory at the time of the study
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
p-toluidine
EC Number:
203-403-1
EC Name:
p-toluidine
Cas Number:
106-49-0
Molecular formula:
C7H9N
IUPAC Name:
p-toluidine
Details on test material:
- Name of test material (as cited in study report): p-toluidine
- Analytical purity: no data

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified

Administration / exposure

Type of coverage:
not specified
Vehicle:
water
Duration of exposure:
Exposure time was not mentioned
Doses:
464, 691, 1000, 1470 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not required

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
890 mg/kg bw
95% CL:
622 - 1 272
Mortality:
464 mg/kg bw: no symptoms, mortality: 1/5 at day 4
691 mg/kg bw: onset of symptoms 4-12 hours post application, mortality: 1/5 day 4, survivors recovered one day post exposure
1000 mg/kg bw: onset of symptoms 0-4 hours post application, mortality: 3/5 12-24 hours and day 4 post exposure, respectively; survivors recovered one day post exposure
1470 mg/kg bw: onset of symptoms 0-4 hours post application, mortality: 5/5 12-24 hours and day 4 post exposure, respectively
Clinical signs:
hypoactivity, muscular weakness, convulsions and vocalisation just prior to death
dermal irritation: moderate to severe erythema, mild edema, focal chemical burns, subdermal hemorrhages
Gross pathology:
survivors: no significant findings
decedents: granular livers

Applicant's summary and conclusion

Executive summary:

Industrial Bio-Test Laboratory Inc (1973).

Dermal application of 464 - 1470 mg/kg bw moistened p-toluidine (exposure time not mentioned) to 5 rabbits/dose group, resulted in an LD50-value of 890 mg/kg bw. Signs of intoxication from day 4 post exposure in the lowest dose group and within 4 hours post exposure in the highest dose group were hypoactivity, muscular weakness, convulsions and vocalisation just prior to death which occurred in all dose groups. Additionally, moderate to severe erythema, mild edema, focal chemical burns and subdermal hemorrhages were seen in the skin of the rabbits. Pathological investigations showed granular livers in the decedents whereas from survivors no significant findings were noted