Undec-10-enoic acid

Endpoint summary

Description of key information

One Klimisch 1 rated key study on acute oral toxicity (Manciaux, 1999) and one Klimisch 1 rated key study on dermal toxicity have been carried out with rats (Manciaux, 1999). According to these studies, there is no relevant acute toxic effect coming from the test item undeceonic acid up to a dose level 2000 mg/kg bw/d, thus there is no classification.

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:

1999-03-24 till 1999-04-07

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Iffa Crédo, L`Arbresle, France
- Age at study initiation: appr. 6 weeks
- Weight at study initiation: 174 +/-7g (males) 135+/-5g females
- Fasting period before study: appr. 18 h (acess to water)
- Housing: sex-separated in groups on dust-free sawdust in polcarbonate cages
- Diet / Water (e.g. ad libitum): ad lib. except for fasting
- Acclimation period: >5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21+/-2
- Humidity (%): 30-70
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

10 ml/ kg BW

Doses:

2000 mg/kg BW

No. of animals per sex per dose:

5

Control animals:

other: historical control

Details on study design:

no

Statistics:

no data

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 2 000 mg/kg bw

Mortality:

Animals were observed for clinical signs and mortality frequently on the day of application, and afterwards once a day for 15 days;none during the whole study.

Clinical signs:

other: Animals were observed for clinical signs and mortality frequently on the day of application, and afterwards once a day for 15 days; hypoactivity and piloerection in one male and one female on day 1 only; no effect on other animals.

Gross pathology:

on day 15: no apparent abnormalities.

Other findings:

no

Table 1: Mean bodyweights (BW)

	historical control	study (2000 mg/kg bw)
MALES Initial BW	182	174
MALES BW day 15	315	295
FEMALES Initial BW	147	135
FEMALES BW day 15	215	193

Interpretation of results:

GHS criteria not met

Conclusions:

Under the experimental conditions, the dermal LD0 of the test substance ACIDE UNDECYLENIQUE is equal or higher than 2000 mg/kg in rats.

Executive summary:

The acute oral toxicity of the test substance ACIDE UNDECYLENIQUE was evaluated in rats according to OECD guideline No. 401 and EU directive 92/69/EEC B.1. The substance was applied to ten (five male and 5 female) Sprague-Dawley rats at a dose of 2000 mg/kg bw. Animals were observed for 15 days. Transient clinical signs (hypoactivity and piloerection) were present in two out of ten animals on the day of treatment only. Mortality, reduction of body weight gain and abnormalities in gross pathology were not evident.

Under the experimental conditions, the dermal LD0 of the test substance ACIDE UNDECYLENIQUE is equal or higher than 2000 mg/kg in rats. No signs of toxicity were observed at this dose.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

other justification

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no study available

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:

1999-03-31 till 1999-04-14

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

SD ICO : OFA-SD (IOPS Caw)
TEST ANIMALS
- Source: Iffa Crédo, L`Arbresle, France
- Age at study initiation: 8 weeks
- Weight at study initiation: 251 +/-4 g (males) 227 +/-12g (females)
- Housing: individually during treatment in polycarvbonate cages on dust-free sawdust
- Diet (e.g. ad libitum): ad lib.
- Water (e.g. ad libitum): ad lib.
- Acclimation period: in groups, at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21+/-2
- Humidity (%): 30-70
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

one single administration of unchanged substance on gauze moistened with 2 ml water

Duration of exposure:

24 h

Doses:

2000 mg /kg BW

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

no data

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 2 000 mg/kg bw

Mortality:

Animals observed frequently on day of treatment, afterwards once daily, for mortality and clinical signs;
no deaths observed.

Clinical signs:

other: Animals observed frequently on day of treatment, afterwards once daily, for mortality and clinical signs; no clinical signs and cutaneous reactions observed.

Gross pathology:

Necropsy and gross pathology was performed on day 15;
macroscopic examination revealed no apparent abnormalities.

Interpretation of results:

GHS criteria not met

Conclusions:

Under the experimental conditions, the dermal LD0 of the test substance Undecylenic Acid is equal or higher than 2000 mg/kg in rats. No signs of toxicity were observed at this dose.

Executive summary:

The acute dermal toxicity of the test substance Undecylenci Acid (named ACIDE UDECYLENIQUE in this report) was evaluated in rats according to OECD No. 402 and EC 92/69/EEC B.3 guidelines. The test substance was applied in its original form at a dose of 2000 mg/kg to the skin of ten Sprague-Dawley rats (five males and five females) for 24 h, and animals were observed for 15 days. Mortality, clinical signs, reduction of body weight gain and abnormalities in gross pathology were not evident.

Under the experimental conditions, the dermal LD0 of the test substance Undecylenic Acid is equal or higher than 2000 mg/kg in rats. No signs of toxicity were observed at this dose.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Additional information

Acute oral :

The acute oral toxicity of the test substance undecylenic acid was evaluated in rats according to OECD guideline No. 401 and EU directive 92/69/EEC B.1 (Manciaux, 1999). The substance was applied to ten (five male and 5 female) Sprague-Dawley rats at a dose of 2000 mg/kg bw. Animals were observed for 15 days. Transient clinical signs (hypoactivity and piloerection) were present in two out of ten animals on the day of treatment only. Mortality, reduction of body weight gain and abnormalities in gross pathology were not evident.

Acute dermal :

The acute dermal toxicity of the test substance undecylenic acid was evaluated in rats according to OECD No. 402 and EC 92/69/EEC B.3 guidelines (Manciaux, 1999). The test substance was applied in its original form at a dose of 2000 mg/kg to the skin of ten Sprague-Dawley rats (five males and five females) for 24 h, and animals were observed for 15 days. Mortality, clinical signs, reduction of body weight gain and abnormalities in gross pathology were not evident.

Under the experimental conditions, the dermal LD0 of the test substance Undecylenic Acid is equal or higher than 2000 mg/kg in rats. No signs of toxicity were observed at this dose.

Justification for classification or non-classification

According to EU regulation (EC) No 1272/2008 (CLP) : undec-10 -enoic acid is not classified for acute toxicity (oral and dermal).

Justification : LD 50> 2000 mg/kg bw