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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
Study period:
1979-06-12 to 1979-07-03
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well conducted study prior to GLP and OECD-TG.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Principles of method if other than guideline:
Administration of the test substance by oral gavage. 10 Animals per dosage group. After administration observation of lethal symptoms, mortality and time of death. Weekly weighting of animals. Necropsy and gross pathology of the dead animals and all surviving animals sacrificed after end of 14 day observation time.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
4-chloro-2,5-dimethoxyaniline
EC Number:
228-782-0
EC Name:
4-chloro-2,5-dimethoxyaniline
Cas Number:
6358-64-1
Molecular formula:
C8H10ClNO2
IUPAC Name:
4-chloro-2,5-dimethoxyaniline

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
- Strain: Hoe WISKf(SPF71)
- Source: Hoechst AG, own breed
- Weight: 180 - 196 g (mean: 187.2 g +/- 4.92 g)
- Diet: Altromin 1324, ad libitum
- Water: tap water, ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: sesame oil
Details on oral exposure:
- Concentration of test substance in vehicle 25%
- Fasting 16 hours before and 2 hrs after administration.
Doses:
800, 2000, 5000 mg/kg bw
No. of animals per sex per dose:
10 females
Control animals:
no
Details on study design:
- Weekly weighing of animals during 14 day observation period after administration of the test substance
- Necropsy and gross pathology of the dead animals and all surviving animals sacrificed after end of 14 day observation time.
Statistics:
- LD50 using probit analysis (Method of Linder and Weber)
- Confidence levels using method of Fieller

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
1 260 mg/kg bw
95% CL:
798 - 1 850
Mortality:
800 mg/kg: 2 of 10 animals
2000 mg/kg: 8 of 10 animals
5000 mg/kg: 10 of 10 animals
Clinical signs:
other: drowsiness, crouched position, ruffeled fur, uncoordinated walk, dark yellow brown discoloration of urine, abdominal position, lateral position, irregular breathing rate, increased lacrimal discharge, narcosis.
Gross pathology:
Necrosis of dead animals: hepatic lobules altered, bladder filled with brown fluid
Necrosis of surviving animals sacrificed at end of study: None.

Applicant's summary and conclusion

Interpretation of results:
other: weakly toxic
Remarks:
Criteria used for interpretation of results: other: Spector "Handbook of Toxicology"
Conclusions:
In the present study a LD50 of 1260mg/kg bw was determined.
Executive summary:

In the present study a LD50 of 1260mg/kg bw was determined.