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

Acute Toxicity: oral

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2020

Report date:

2020

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Reference substance name:

Constituent C25H31N | Nonyl (branched) substituted - N-Phenyl-1-naphthylamine

Molecular formula:

C25H31N

IUPAC Name:

Constituent C25H31N | Nonyl (branched) substituted - N-Phenyl-1-naphthylamine

Constituent 2

Reference substance name:

Constituents C34H49N | Di-nonyl (branched)- substituted N-Phenyl-1-naphthylamine

Molecular formula:

C34H49N

IUPAC Name:

Constituents C34H49N | Di-nonyl (branched)- substituted N-Phenyl-1-naphthylamine

Test material form:

liquid

Details on test material:

Name of test item: XPDL 958
Test item No.: 20/0205-1
Batch identification: 0021851006
CAS No.: 63451-49-0
Purity: 100% UVCB *; additionally, an analytical characterization was conducted (No. 20L00034).
Homogeneity: The test item was homogeneous by visual inspection.
Storage stability: The stability of the test item under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility.
Expiry date: November 18, 2021
Storage conditions: Room temperature
Physical state / color: Liquid, viscous/ brown to red

Test animals

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- Fasting period before study: Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.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

Administration / exposure

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

Results and discussion

Effect levels

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).

Applicant's summary and conclusion

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.