Benzenemethanimine, .alpha.-phenyl-

Endpoint summary

Description of key information

LD50 (oral, rat) > 2000 mg/kg bw (OECD TG 423, GLP).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes

Test type:

acute toxic class method

Specific details on test material used for the study:

- Name of test material (as cited in study report): BPI (Benzophenone imine)
- Analytical purity: 94.8 %
- Lot/batch No.: 11/94 CONTAINER 13
- Physical state: liquid, light yellow
- Stability under test conditions: proven by reanalysis
- Storage condition of test material: refrigerator

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach
- Age at study initiation: Young adult animals
- Weight at study initiation: 150 - 300 g (+/- 20%)
- Fasting period before study: at least 16 hours before administration, but water was available ad libitum
- Housing: single housing in stainless steel wire mesh cages, type DK-III (Becker & Co., Castrop-Rauxel, FRG)
- Diet: Kliba-Labordiaet 343 (Klingentalmuehle AG, Kaiseraugst, Switzerland) ad libitum
- Water: Tap water ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12 (6.00 pm - 6.00 am dark / 6.00 am - 6.00 pm light)

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 4 g/100 ml and 40 g/100 ml
- Justification for choice of vehicle: the test substance is sensitive to hydrolysis

MAXIMUM DOSE VOLUME APPLIED: 5 ml/kg bw

CLASS METHOD
- Rationale for the selection of the starting dose: Based on the physical and chemical characteristics of the test substance and the composition, no pronounced acute oral toxicity was expected. Therefore a dose of 2000 mg/kg bw has been chosen for the first step with 3 male animals.

Doses:

2000 mg/kg bw and 200 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 200 mg/kg bw : 14 days, 2000 mg/kg bw : 14 days for males , 15 days for females
- Frequency of observations and weighing: individual body weights were determined shortly before application, weekly thereafter and at the end of the study. A check was made twice each workday and once on saturdays, sundays and on public holidays for general observations and for any dead or moribund animals.
- Necropsy of survivors performed: yes (withdrawel of food at least 16 hours before killing with CO2)
- Other examinations performed: clinical signs and symptoms were recorded several times on the day of administration and at least once each workday

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

See table 1. No mortality was observed at 200 mg/kg. 2/6 animals died at 2000 mg/kg (2/3 females 0/3 males). There is however no hint for a real sex difference.

Clinical signs:

Impaired or poor general state, dyspnoea, apathay, staggering, salivation, exsiccosis, red clammy snout and eyelid and red smeared fur in the anogenital area noted in male or female animals of the 2000 and 200 mg/kg dose group. The surviving animals appeared normal within 6 days after application.

Body weight:

The expected body weigt gain has been observed in the course of the study.

Gross pathology:

No abnormalities were noted at necropsy.

Table. 1: Mortality

	3 days	4 days	14 days
200 mg/kg (male)	0/3	0/3	0/3
200 mg/kg (female)	0/3	0/3	0/3
2000 mg/kg (male)	0/3	0/3	0/3
2000 mg/kg (female)	1/3	2/3	2/3

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 (ora, rat) > 2000 mg/kg bw.

Executive summary:

The study was performed to assess the range of mortality following oral administration of the test substance, applied as an emulsion in olive oil DAB 10 to Wistar rats.

The study procedure was based on the EEC guideline and modified according to the Acute Toxic Class method. To each group of 6 fasted animals (3 males and 3 females) a single oral dose of test material preparation in olive oil DAB 10 at dose levels of 200 and 2000 mg/kg bw was given.

Signs of toxicity noted in male or female animals of the 2000 and 200 mg/kg dose group comprised impaired or poor general state, dyspnoea, apathy, staggering, salvination, exsiccosis, red clammy snout and eyelid and red smeared fur in the anogenital area. These symptoms are considered to be unspecific. The surviving animals appeared normal within 6 days after application. The expected body weight gain has been observed in the course of the study. 2/6 animals died at 2000 mg/kg (2/3 females 0/3 males). There is, however, no hint for a real sex difference. Necropsy of one animal that died was agonal congestion. No abnormalities were noted at necropsy of animals sacrificed at the end of the study.

The oral LD50 (male/female) was determined to be > 2000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

The study was performed to assess the range of mortality following oral administration of the test substance, applied as an emulsion in olive oil DAB 10 to Wistar rats.

The study procedure was based on the EEC guideline and modified according to the Acute Toxic Class method. To each group of 6 fasted animals (3 males and 3 females) a single oral dose of test material preparation in olive oil DAB 10 at dose levels of 200 and 2000 mg/kg bw was given.

Signs of toxicity noted in male or female animals of the 2000 and 200 mg/kg dose group comprised impaired or poor general state, dyspnoea, apathy, staggering, salvination, exsiccosis, red clammy snout and eyelid and red smeared fur in the anogenital area. These symptoms are considered to be unspecific. The surviving animals appeared normal within 6 days after application. The expected body weight gain has been observed in the course of the study. 2/6 animals died at 2000 mg/kg (2/3 females 0/3 males). There is, however, no hint for a real sex difference. Necropsy of one animal that died was agonal congestion. No abnormalities were noted at necropsy of animals sacrificed at the end of the study.

The oral LD50 (male/female) was determined to be > 2000 mg/kg bw.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. For acute oral toxicity a LD50 > 2000 mg/kg bw/d was determined. No information on the acute toxicity o the inhalation or dermal route is available. As a result, the substance is not considered to be classified for acute toxicity under Regulation (EC) No. 1272/2008, as amended for the thirteenth time in Regulation (EC) No. 2018/1480.