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Administrative data

Description of key information

Two Klimisch 1 rated key studies on acute oral toxicity (1997, 1999) and one Klimisch 1 rated key study on dermal toxicity have been carried out withrats (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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study (OECD 401)
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to
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 and environmental conditions:
no
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 2.07 ml/kg BW
Doses:
2000 mg/kg BW
No. of animals per sex per dose:
5
Control animals:
other: historical controls
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weighing on day 1, 8 and 15
- 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:
none
Clinical signs:
none
Body weight:
normal gain
Gross pathology:
no findings
Other findings:
no
Conclusions:
According to GHS-criteria, no classification of Ethoxylated Undecylenic Acid (+2EO) is required
Executive summary:

The acute oral toxicity of the test substance Ethoxylated Undecylenic Acid (+2 EO) was evaluated in rats according to OECD guideline No. 401 and EU directive 92/69/EECB1. The test substance was administered by oral gavage to ten (five male and five female) fasted Sprague-Dawley rats. The animals were observed for 14 days. General behaviour and body weight gain were not affected by substance treatment. Mortailty and abnormalities in gross pathology were not observed. Under the experimental conditions, the oral LD0 of the test substance Ethoxylated Undecylenic Acid (+2EO) was higher or equivalent to 2000 mg/kg in rats. No signs of toxicity were observed at this dose.

Endpoint conclusion
Dose descriptor:
discriminating dose
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:

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:
other: GLP-study without deviations according to OECD-guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
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 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:
Animals observed frequently on day of treatment, afterwards once daily, for mortality and clinical signs;
no clinical signs and cutaneous reactions observed.
Body weight:
Body weight was monitored on day 1 and 15; body weight gain not influenced by treatment.
Gross pathology:
Necropsy and gross pathology was performed on day 15;
macroscopic examination revealed no apparent abnormalities.
Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
According to GHS criteria, no classification of Undecylenic Acid is required.
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
Dose descriptor:
discriminating dose
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. 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. 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 Directive 67/584/EEC and 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