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Endpoint summary

Description of key information

Acute oral toxicity testing was conducted on the registered substance in accordance with the OECD Testing Guideline 423. No mortality was observed at up to 2,000 mg/kg bw.

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

Study period:

28 September 2020 - 27 October 2020

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

2008

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

2002

Deviations:

no

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

2001

Deviations:

no

GLP compliance:

yes (incl. QA statement)

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 Deutschland, Sulzfeld, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: approximately 9-10 weeks old
- Weight at study initiation: 140 to 196 g
- Fasting period before study: Yes, o/n (for a maximum of 20 hours) prior to dosing and until 3-4 hours after administration of the test item. Water was available.
- Housing: animals were group housed (up to 3 animals of the same sex and same dosing group together) in polycarbonate cages containing sterilized wooden fibers as bedding material equipped with water bottles.
- Animal enrichment: animals were provided with paper, except when interrupted by study procedures/activities.
- Diet: Pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany), ad libitum (except during designated procedures). The feed was analyzed by the supplier for nutritional components and environmental contaminants.
- Water: Municipal tap water, ad libitum. Periodic analysis of the water was performed.
- Contaminants: It is considered that there were no known contaminants in the feed or water that would interfere with the objectives of the study.
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 24°C (target range); 21°C (actual daily mean)
- Humidity (%): 40 to 70% (target range); 40 to 65% (actual daily mean)
- Air changes (per hr): 10 or greater air changes per hour
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark cycle

IN-LIFE DATES: From: 29 September 2020 To: 27 October 2020

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Supplier: Sigma-Aldrich, Steinheim, Germany
- Justification for choice of vehicle: Trial preparations were performed to select the suitable vehicle and to establish a suitable formulation procedure. These trials were not performed as part of this study and these preparations were not used for dosing.
- Specific gravity: 0.92

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg body weight

CLASS METHOD
- Rationale for the selection of the starting dose: The dose levels were based on the OECD test guidelines and were selected from the series 5 (lowest dose level), 50, 300 and 2000 (highest dose level) mg/kg body weight. The starting dose level should be the one that is likely to produce mortality in at least some of the animals and was selected based on available toxicity data of the test item.

Doses:

2000 mg/kg

No. of animals per sex per dose:

Group 1: 3 females
Group 2: 3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: Post-dose observations were performed at periodic intervals on the day of dosing (at least three times) and once daily thereafter.
- Frequency of weighing: Day 1 (pre-dose), 8 and 15. A fasted weight was recorded on the day of dosing.
- Necropsy of survivors performed: yes

Statistics:

No statistical analysis was performed.

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality occurred.

Clinical signs:

other: Hunched posture and erected fur were noted for all animals between Days 1 and 3. Three animals also showed pale/orange colored feces between Days 1 and 9.

Gross pathology:

An abnormality of the kidney (right enlarged) in one animal and the thoracic body cavity (dark red fluid accumulation) in another animal was found at macroscopic post mortem examination. Macroscopic post mortem examination of the other animals at termination did not reveal any abnormalities.
An abnormality of the clitoral gland (dark tanned bilateral multifocal foci) was observed in one animal, however, this is more often seen in rats of this strain in this kind of study and therefore no toxicological relevance was attached to this finding.

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of an acute oral study, performed according to OECD guideline 423 and in accordance with GLP principles, the oral LD50 value of Reaction products of 1,3-cyclohexanedimethanamine and 12-hydroxystearic acid (BA-1801) in Wistar Han rats was determined to exceed 2000 mg/kg bodyweight. As a consequence, Reaction products of 1,3-cyclohexanedimethanamine and 12-hydroxystearic acid (BA-1801) is not classified according to Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).

Executive summary:

An acute oral study was performed according to OECD guideline 423 and in accordance with GLP principles, six female rats were exposed at test item concentration of 2000 mg/kg bodyweight and observed for 14 days. No mortality occured. Hunched posture and erected fur were noted for all animals between Days 1 and 3. Three animals also showed pale/orange colored feces between Days 1 and 9. The body weight gain shown by the animals over the study period was considered to be similar to that expected for normal untreated animals of the same age and strain. An abnormality of the kidney (right enlarged) in one animal and the thoracic body cavity (dark red fluid accumulation) in another animal was found at macroscopic post mortem examination. Macroscopic post mortem examination of the other animals at termination did not reveal any abnormalities. The oral LD50 value of Reaction products of 1,3-cyclohexanedimethanamine and 12-hydroxystearic acid (BA-1801) in Wistar Han rats was established to exceed 2000 mg/kg body weight. Based on these results, Reaction products of 1,3-cyclohexanedimethanamine and 12-hydroxystearic acid (BA-1801) does not have to be classified and has no obligatory labelling requirement for acute oral toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2017) (including all amendments) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD0

Value:

2 000 mg/kg bw

Quality of whole database:

Testing was GLP-compliant and conducted in accordance with a relevant OECD Testing Guideline.

Additional information

Acute Oral Toxicity
An acute oral study was performed according to OECD guideline 423 and in accordance with GLP principles, six female rats were exposed at test item concentration of 2000 mg/kg bodyweight and observed for 14 days. No mortality occured. Hunched posture and erected fur were noted for all animals between Days 1 and 3. Three animals also showed pale/orange colored feces between Days 1 and 9. The body weight gain shown by the animals over the study period was considered to be similar to that expected for normal untreated animals of the same age and strain. An abnormality of the kidney (right enlarged) in one animal and the thoracic body cavity (dark red fluid accumulation) in another animal was found at macroscopic post mortem examination. Macroscopic post mortem examination of the other animals at termination did not reveal any abnormalities. The oral LD50 value of Reaction products of 1,3-cyclohexanedimethanamine and 12-hydroxystearic acid (BA-1801) in Wistar Han rats was established to exceed 2000 mg/kg body weight.

Justification for classification or non-classification

Based on the results of an acute oral study, performed according to OECD guideline 423 and in accordance with GLP principles, the oral LD50 value of Reaction products of 1,3-cyclohexanedimethanamine and 12-hydroxystearic acid (BA-1801) in Wistar Han rats was determined to exceed 2000 mg/kg bodyweight. As a consequence, Reaction products of 1,3-cyclohexanedimethanamine and 12-hydroxystearic acid (BA-1801) is not classified according to Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).