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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
comparable to guideline study with acceptable restrictions
Remarks:
performed prior to guideline and GLP implementation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1977

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: company guideline similar to OECD 401
Deviations:
no
GLP compliance:
no
Remarks:
performed prior to GLP implementation
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3-hydroxy-3'-nitro-2-naphthanilide
EC Number:
205-209-2
EC Name:
3-hydroxy-3'-nitro-2-naphthanilide
Cas Number:
135-65-9
Molecular formula:
C17H12N2O4
IUPAC Name:
3-hydroxy-N-(3-nitrophenyl)-2-naphthamide
Test material form:
solid
Details on test material:
purity: 99.7%
Product number HKAG 155

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS

- Weight at study initiation: 108 - 136 g, mean: 120 g
- Fasting period before study: 16 h
- Housing: Plastic cage, wood shavings bedding
- Diet (e.g. ad libitum): ALTROMIN 1324, Altromin GmbH in Lage/Lippe, ad libitum
- Water (e.g. ad libitum):tap water, ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: sesame oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 25%

MAXIMUM DOSE VOLUME APPLIED: 5000 mg/kg bw
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10 female
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of weighing: weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortality
Clinical signs:
other: no clinical signs
Gross pathology:
no abnormal findings
Other findings:
no other findings reported

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
The test item has not to be classified as acutely toxic by the oral route according to Regulation (EC) No 1272/2008.
Conclusions:
LD50: > 5000 mg/kg bw, no other abnormalities observed

Therefore, the test item has not to be classified as acutely toxic by the oral route (including STOT SE) according to Regulation (EC) No 1272/2008.
Executive summary:

The substance was tested for acute oral toxicity according to a company guideline similar to OECD 401. 10 female SPF-Wistar-rats were administered a 25% suspension of the test item in sesame oil by gavage. A single dose of 5000 mg/kg bw was used. The observation time after application was 14 days. No mortality occured and the section of the animals resulted in no significant findings.

The LD50 is determined to be greater than 5000 mg/kg bw

Therefore, the test item has not to be classified as acutely toxic by the oral route (including STOT SE) according to Regulation (EC) No 1272/2008.