Hexanoic acid, 2-ethyl-, C12-15-alkyl esters

Endpoint summary

Description of key information

Study conducted to recognised testing guidelines with GLP certification where appropriate.

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:

1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Version / remarks:

17 July 1992

Deviations:

no

GLP compliance:

no

Remarks:

Study conducted prior to GLP guidelines and regulations.

Test type:

fixed dose procedure

Limit test:

yes

Species:

rat

Strain:

other: Albino (otherwise not specified)

Sex:

male/female

Details on test animals or test system and environmental conditions:

200-280g bodyweight each.

Route of administration:

oral: unspecified

Vehicle:

unchanged (no vehicle)

Doses:

5g/kg bw

No. of animals per sex per dose:

5 males:5 females

Control animals:

no

Details on study design:

Animals were observed for pharmacologic activity and drug toxicity 1, 3, 6, and 24 hours after treatment, and daily thereafter for a total of 14 days.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed during the observation period (14 days after dosing).

Clinical signs:

other: No effects observed.

Gross pathology:

No effects observed.

Observed mortality:

Dose level (g/kg)	Sex	No. dead/No. Dosed (M:F)	Mortality (%)
5	5M:5F	0/5 : 0/5	0

Interpretation of results:

GHS criteria not met

Conclusions:

The test material was determined to have a acute oral toxicity LD50 of >5000 mg/kg bw in the rat, under the conditions of the test.

Executive summary:

Ten (5M:5F) albino rats, 200 -280g, each received a single dose of the test article at a dose level of 5g/kg bw. Animals were observed for pharmacologic activity and drug toxicity 1, 3, 6, and 24 hours adfter treatment, and daily thereafter for a total of 14 days. Non-survivors and animals surviving the 14 day obnservation period were subject to gross necropsy, with all findings noted. The test article was used as received (Sp.g. = 0.83).

LD50: 5 g/kg bw (5000 mg/kg bw)

This test article is not toxic orally to rats under the conditions of the test.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

1

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

study waived due to provisions of other regulation

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Quality of whole database:

1

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

6 May 1992 - 20 May 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

12 May 1981

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Specific details on test material used for the study:

A sample of the test material was received in April 30, 1992 and identified with entry n. 1599/1.

Analysis:

No analysis was carried out on the sample as all relevant data was provided by the Sponsor.

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Species: Rats
Strain: Wistar
N.: 10 (5 males and 5 females)
Weight: 200-300 g at the beginning of the study
Sex: Males and Females
Supplier: Morini - S. Polo d'Enza (RE) - ITALY -

These rats were chosen as they are of the 2 species recommended by the Ministerial decree of December 5, 1983 and by OECD Guidelines and also because they are the same species used in the other toxicity test (oral).

- Caging:
The animals were caged in groups of 5 of the same gender in transparentpolycarbonate cages (dimensions mm 425x266x180h) .
The housing room was mantained under the following conditions:
Temperature: 20°C ± 2°C
Humidity: 55% ± 15%
R.H.: air was changed at least 25 times per hour and maintained at a pressure higher than the outside atmosphere
Artificial lighting: 12 h!day

- Cleaning and disinfection:
The cages and the housing room were cleaned and disinfected before the animals were accomodated, then cleaning and disinfection were performed periodically.

- Feeding:
Animals were fed with standard pellet complete diet supplied .by the authorized breeder Morini.

- Watering:
Filtered tap water from local network was supplied ad libitum.

- Animal identification:
Each animal was identified with an indelible colouring in different parts of the body.
No sign: 1
Head: 2
Back: 3
Tail: 4
Head + tail: 5

Cages were labelled.

- Quarantine:
Before being used in this study, the animals were kept in quarantine for one week. During this period they were observed daily. At the end of the quarantine week the animals were carefully examined in order to evaluate their suitability for the study.

- Animal selection:
The animals used for this study were selected randomly from those suitable, available at that time.

Type of coverage:

not specified

Vehicle:

other: Sesame oil

Details on dermal exposure:

- PREPARATION OF TEST MATERIAL:
A solution was prepared in sesame seed oil at a concentration of 200 mg/ml.

- EXPERIMENTAL DESIGN:
10 rats were used (5 males, 5 females).
No control group was used as it is documented that sesame seed oil is non toxic.
The animals were treated with a dose of 2000 mg/kg and was administered at a volume of 10 ml/kg.

- ADMINISTRATION:
The test material (10 ml/kg) was administered in one dose and applied directly on the skin.

Duration of exposure:

14 days

Doses:

The animals were treated with a dose of 2000 mg/kg which was administered at a volume of 10 ml/kg.
The test material (10 ml/kg) was administered in one dose and applied directly on the skin.

Control animals:

no

Details on study design:

All procedures followed during this study conform to the Biolab
S.G.S. Standard Operating Procedures, as recorded and shown in
the Biolab Procedures Manual.

Preparation of test material

A solution was prepared in sesame seed oil at a concentration of 200 mg/ml.

Experimental design

10 rats were used (5 males, 5 females).
No control group was used as it is documented that sesame seed oil is non toxic.
The animals were treated with a dose of 2000 mg/kg and was administered at a volume of 10 ml/kg.

Administration
The test material (10 ml/kg) was administered in one dose and applied directly on the skin.

Observations

General conditions of the animals were controlled daily for 14 days. All data relative to the study, including observations and examination were recorded and signed daily. Observations included:

Mortality
Animals were observed in the morning of every working day.

Clinical signs and behavior
Every clinical symptom, including possible variations in somotomotor activity, was daily recorded in every single animal. Clinical observations included:
- tegumentary apparatus
- mucosae conditions
- respiratory activity
- sensorium conditions

Body weight
Animals were weighed before the experiment, after 7 days and then at the end of the study.

Necropsy
At the end of the observation period rats were sacrificed and a necroptic survey was performed.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No death occurred during the study among the treated animals.

Clinical signs:

other: No clinical signs were observed during the experimental observation period.

Gross pathology:

At the ante-mortem and post-mortem examination in all animals no pathological symptoms were observed. Nothing abnormal was found in the autopsy on the animals.

Interpretation of results:

GHS criteria not met

Conclusions:

The acute dermal LD50 of the test material in the rat was found to be >2000 mg/kg bw under the conditions of the test.

Executive summary:

The test of acute dermal toxicity was performed on a group of ten rats (5 male and 5 females). The test material, COSMACOL EOI, was administered at a dose of 2000 mg/kg by dermal application. During the study the animals were observed daily for 14 days (5 out of 7) for signs of toxic symptoms. These signs were:

mortality;

evaluation of body functions;

evaluation of the tegumentary apparatus;

evaluation of mucosa conditions;

evaluation of possible variations in somatomotory activity

and sensorium conditions.

Body weight was recorded weekly.

At the end of the test autopsy was carried out on all animals.

The results obained during the study can be summarized as follows:

Mortality

During the study no case of mortality occurred.

Clinical symptoms

No clinical symptoms related to the test were observed.

Weight increase

Weight increase was normal for this species.

Necropsy findings

Animals showed no pathological symptoms.

Nothing abnormal was found in the autopsy.

DL50

The lethal dose 50 is superior 2000 mg/kg.

Under experimental conditions the test material COSMACOL Eor was found to be NON TOXIC.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

1

Justification for classification or non-classification

The registered substance does not fulfill the criteria for classification as acutely toxic according to the Classification, Labelling, and Packaging (CLP) regulation (1272/2008).