Reaction products of N-Phenyl-1-Naphthylamine with Nonene, branched

Endpoint summary

Description of key information

LD50(oral, rat) > 2000 mg/kg bw/d (BASF, 2020)

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)

Version / remarks:

December 17, 2001

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Females (if applicable) nulliparous and non-pregnant: [yes]
- Age at study initiation: Young adult animals (female animals approx. 9-10 weeks)
- Weight at study initiation: Animals of comparable weight (± 20% of the mean weight)
- Fasting period before study: Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.
- Housing: Single housing, Makrolon cage, type III
- Diet: ad libitum
- Water: ad libitum
- Acclimation period:
Acclimatization period of at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +- 3°C
- Humidity (%): 30 – 70%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: capsule

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The homogeneity of the test item during administration was ensured by stirring with a magnetic stirrer.
Administration volume (mL/kg bw): 1.96

Doses:

2000 mg/kg

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

EXPERIMENTAL PROCEDURE
Route of administration: Single oral administration by gavage.
Fasting period: Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.
Time of day of administration: In the morning
Observation period: 14 days
Body weight determination: Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation.
Clinical observations: Clinical signs for each animal were recorded several times on the day of administration and at least once during each workday thereafter.
Mortality: A check for any dead or moribund animals was made at least once each workday; these records are archived by Bioassay.
Pathology: Necropsy with gross-pathology examination was performed on the last day of the observation period after sacrifice by CO2-inhalation in a chamber with gradually increasing concentrations.
Histology: No histological examinations were performed.

Statistics:

Not applicable

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred in both test groups.

Clinical signs:

other: In the first test group, impaired general state was seen in two out of three animals from study day 2 until study day 3 after administration. The third animal did not show any symptoms. In the second administration group, no clinical signs were observed d

Gross pathology:

There were no macroscopic pathological findings in any animal sacrificed at the end of the observation period (6 females).

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study the median lethal dose of XPDL 958 after oral administration was assessed to be greater than 2000 mg/kg bw in rats.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Additional information

Acute oral toxicity

In an acute oral toxicity study performed according to the Acute Toxic Class Method (OECD TG 423 and GLP), a dose of 2000 mg/kg bw of the undiluted test item XPDL 958 was administered by gavage to two test groups of three fasted Wistar rats each (6 females) (BASF, 2020).

The following test substance-related clinical observations were recorded, clinical signs occurred within 3 days after administration:

2000 mg/kg (first test group):

- No mortality occurred

- Impaired general state in two animals

2000 mg/kg (second test group):

- No mortality occurred

- No clinical signs were observed.

All animals gained weight in a normal range throughout the study period. There were no macroscopic pathological findings in any animal sacrificed at the end of the observation period (6 females).

The acute oral LD50 was assessed to be LD50, oral, rat > 2000 mg/kg bw

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. The acute oral LD50 was determined to be greater than 2000 mg/kg bw. As a result the substance is not classified and labelled under Regulation (EC) No 1272/2008.