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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1977
Report date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Remarks:
- prior to GLP
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
4'-chloro-2',5'-dimethoxyacetoacetanilide
EC Number:
224-638-6
EC Name:
4'-chloro-2',5'-dimethoxyacetoacetanilide
Cas Number:
4433-79-8
Molecular formula:
C12H14ClNO4
IUPAC Name:
N-(4-chloro-2,5-dimethoxyphenyl)-3-oxobutanamide
Details on test material:
- Name of test material (as cited in study report): Naphtanilide LRG

Test animals

Species:
rat
Strain:
other: CFY
Sex:
male/female
Details on test animals or test system and environmental conditions:
Weight range: 91 to 131 g

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: aqueous methylcellulose (0.5 %)
Doses:
0 (control), 320, 500, 800, 1260, 2000, 5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
850 mg/kg bw
Mortality:
0 (control): male 0 of 5, female 0 of 5
320 mg/kg bw: male 0 of 5, female 0 of 5
500 mg/kg bw: male 1 of 5, female 1 of 5
800 mg/kg bw: male 1 of 5, female 1 of 5
1260 mg/kg bw: male 5 of 5, female 5 of 5
2000 mg/kg bw: male 5 of 5, female 5 of 5
5000 mg/kg bw: male 5 of 5, female 5 of 5
Clinical signs:
other: Shortly after dosing: Lethargy, pilorection, hunched posture. Ataxia at 320 mg/kg bw and above. Increased lacrimation, and prior to death decreased respiratory rate and coma at 800 mg/kg bw and above.
Gross pathology:
No abnormal findings neither in lethally intoxicated nor in surving animals.
Other findings:
no other findings

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The acute median lethal oral dose (LD50) to rats of Naphtanilidine LRG was calculated to be 850 mg/kg body weight.
Executive summary:

Naphtanilide LRG was tested for acute oral toxicity following a protocol similar to OECD 401. Single doses of 0 (control), 320, 500, 800, 1260, 2000, 5000 mg/kg bw were tested by administering 5 or 20% Naphtanilide LRG in aqueous methylcellulose (0.5 %) once per oral gavage to 10 (5 male, 5 female) CFY rats per dose. Body weight range was 91 to 131 g. Rats were starved overnight before treatment. Post administrational observation period was 14 days.

The acute median lethal oral dose (LD50) to rats of Naphtanilidine LRG was calculated to be 850 mg/kg body weight.