Esterification product of Nonanoic acid with C9-11, C10-rich alcohols, branched

Endpoint summary

Description of key information

oral: LD 50 > 5000 mg/kg bw (rat)

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 420 (Acute Oral Toxicity - Fixed Dose Method)

Version / remarks:

July 1992

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Version / remarks:

December 1992

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

no

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 4FP90
- Expiration date of the lot/batch: August 1996

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature, darkness

Species:

rat

Strain:

Wistar

Remarks:

Shoe:WIST

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Tierzucht Schönwalde GmbH D-16352 Schönwalde
- Weight at study initiation: 131 - 173 g.
- Fasting period before study: 18 h prior dosing
- Housing: transparent polycarbonate cages (macrolone type III, floor area 810 cm2
- Diet: ad libitum, complete rodent diet "Altromin 1314"
- Water: ad libitum, domestic quality drinking water acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth
- Acclimation period: 7 day

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

other: sesame oil

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

Doses:

The study was initiated with a sighting study: One female rat was given 2000 mg/kg bw and two days later another rat was given
5000 mg/kg bw. Only slight signs of toxicity were observed in these rats.
On the basis of the results from the sighting study it was decided to carry out the main study with one group consisting of five male and five female rats given a dose of 5000 mg/kg bw. The dose volume administered was 10 mL/kg bw both in sighting and main study.

No. of animals per sex per dose:

5

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Each rat was observed 1, 3 and 6 hours after administration and thereafter daily for a period of 14 consecutive days. Body weight was recorded on days 0, 7 and 14.
- Necropsy of survivors performed: yes
All rats were killed by inhalation of C02 on day 14 and subjected to a gross necropsy examination.

Preliminary study:

The animals included in the sighting study survived the treatment. The rats had a body weight loss on day 14. In animal 1 (2000 mg/kg bw) piloerection was observed 1, 3 and 6 hours after application as well as on days 1 to 4. A pinched abdomen was observed 3 and 6 hours after application. In animal 2 (5000 mg/kg bw) piloerection was observed 1, 3 and 6 hours after application as well as on days 1 to 3. This animal showed a pinched abdomen after 1, 3 and
6 hours and on day 1. The animal was depressed after 3 and 6 hours. The post martern inspection revealed no abnormalities.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

None of the animals died after 5000 mg/kg bw in the main study.

Clinical signs:

other: Four male animals showed a pinched abdomen and piloerection 1, 3 and 6 hours after application. One animal was depressed and had pinched abdomen and piloerection 1 hour after application. This animal showed signs of coma after 3 hours and 6 hours after ap

Gross pathology:

The gross necropsy of male and female rats revealed no abnormalities.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

5 000 mg/kg bw

Quality of whole database:

GLP and guideline study (OECD TG 420)

Additional information

Oral

The acute oral toxicity of the test item was determined according to OECD TG 420 (Fixed dose method) and EU Guideline B.1 „Acute toxicity (oral).

The study was initiated with a sighting study, in which one female rat received 2000 mg/kg bw and another rat 5000 mg/kg bw of the test item by gavage. Only slight signs of toxicity were observed in these rats. In the main study, 5 female and male rats received a dose of 5000 mg/kg bw. All animals of the main study survived and showed only slight signs of toxicity. The LD50 of the test item under the experimental conditions described was above 5000 mg/kg bw (Henkel R9600883; 1996).

Justification for classification or non-classification

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

The available experimental test data is reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is not considered to be classified for acute oral toxicity under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.