3-hydroxy-2'-methoxy-2-naphthanilide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1.-15.07.1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Test performed prior to the implementation of the current acknowledged testing and GLP guidelines . The test conduct however was in principle very similar to the OECD TG 401 as adopted in 1981. Important aspects (e.g. 14 day-postobservation time) were considered.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Remarks:

pre-guideline study

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-hydroxy-2'-methoxy-2-naphthanilide

EC Number:

205-206-6

EC Name:

3-hydroxy-2'-methoxy-2-naphthanilide

Cas Number:

135-62-6

Molecular formula:

C18H14NNaO3

IUPAC Name:

3-hydroxy-2'-methoxy-2-naphthanilide

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Hoe WISKf (SPF71)
- Source: Hoechst AG, breeding colony
- Weight at study initiation: 92 to 106 g, average 99 g
- Fasting period before study: 16 hours
- Housing: plastic cages
- 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:

VEHICLE
- Concentration in vehicle: 10 % suspension (w/v)

Doses:

5.000 mg/kg bw

No. of animals per sex per dose:

10 females

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of weighing: weekly
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Remarks on result:

other: no animals died within the 14 days observation period

Mortality:

none

Clinical signs:

none

Body weight:

- body weight development within normal range (+ 34 %)

Gross pathology:

No findings

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

Single application of the limit dose of 5.000 mg test item per kg bw did not cause any lethality in female rats during the 14 days observation period, resulting in a LD50 > 5.000 mg/kg bw.

Executive summary:

Female rats were subjected to test acute oral toxicity. The test item was administered at the limit dose of 5.000 mg/kg bw to 10 female rats. There was no mortality during the 14 days observation period. No clinical signs or macroscopic findings were observed.

Thus leading to a LD50 > 5.000 mg/kg bw. Therefore, the test item has not to be classified for acute oral toxicity according to Regulation (EC) No 1272/2008.