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Diss Factsheets

Administrative data

Description of key information

Short-term repeated dose oral toxicity (OECD 422) (read-across from supporting substance, structural analogue EC 662-772-0):

The oral administration of 9-decenoic acid, methyl ester (9DAME) to rats by gavage, at dose levels of 30, 300 and 1000 mg/kg bw/day did not result in any toxicological significant effects. The ‘No Observed Adverse Effect Level’ (NOAEL) for systemic  toxicity was therefore considered to be 1000 mg/kg bw/day.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
Endpoint:
short-term repeated dose toxicity: oral
Remarks:
combined repeated dose and reproduction / developmental screening
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
The study was performed between 23 November 2011 and 15 May 2012
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
KL2 due to RA
Justification for type of information:
Read-across justification: A comparison target substance (9DDAME) and the read-across substance (9DAME) shows that the two substances share structural similarities, increasing from a chain length of C10 to C12 with similar functional groups and also have ‘mechanistic action’ similarities.
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
GLP compliance:
yes (incl. QA statement)
Remarks:
Date of inspection 2011-06-27 to 2011-07-21; Date of signature 2011-08-15
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
arachis oil
Analytical verification of doses or concentrations:
yes
Duration of treatment / exposure:
Up to eight weeks (including a two week pre-pairing phase, pairing, gestation and early lactation for females).
Frequency of treatment:
Test item was administered daily
Remarks:
Doses / Concentrations:
0, 30, 300 and 1000 mg/kg bw/day. Treatment volume (4 ml/kg) corresponding to concentrations of 7.5, 75 and 250 mg/ml respectively
Basis:

No. of animals per sex per dose:
10
Control animals:
yes, concurrent vehicle
Statistics:
Where considered appropriate, quantitative data was subjected to statistical analysis to detect the significance of intergroup differences from control; statistical significance was achieved at a level of p<0.05. Statistical analysis was performed on the following parameters: Grip Strength, Motor Activity, Body Weight, Body Weight Change, Food Consumption during gestation and lactation, Haematology, Blood Chemistry, Absolute Organ Weights, Body Weight- Relative Organ Weights

Data were analysed using the decision tree from the ProvantisTM Tables and Statistics Module

Where appropriate, data transformations were performed using the most suitable method. The homogeneity of variance from mean values was analysed using Bartlett’s test. Intergroup variance were assessed using suitable ANOVA, or if required, ANCOVA with appropriate covariates. Any transformed data were analysed to find the lowest treatment level that showed a significant effect, using the Williams Test for parametric data or the Shirley Test for non-parametric data. If no dose response was found, but the data shows non-homogeneity of means, the data were analysed by a stepwise Dunnett’s (parametric) or Steel (non-parametric) test to determine significant difference from the control group. Where the data were unsuitable for these analyses, pair-wise tests was
performed using the Student t-test (parametric) or the Mann-Whitney U test (nonparametric).

Data not analysed by the Provantis data capture system were assessed separately using the SPSS statistical package.
Probability values (p) were calculated as follows:
p<0.001 ***
p<0.01 **
p<0.05 *
p?0.05 (not significant)




















Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed
Food efficiency:
no effects observed
Water consumption and compound intake (if drinking water study):
no effects observed
Ophthalmological findings:
not examined
Haematological findings:
no effects observed
Clinical biochemistry findings:
no effects observed
Urinalysis findings:
not examined
Behaviour (functional findings):
no effects observed
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Histopathological findings: neoplastic:
no effects observed
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: oral administration of test substance was well tolerated at dosage levels of 30, 300, and 1000 mg/kg/day.
Critical effects observed:
not specified
Conclusions:
The oral administration of 9-decenoic acid, methyl ester (9DAME) to rats by gavage, at dose levels of 30, 300 and 1000 mg/kg bw/day did not result in any toxicological significant effects. The ‘No Observed Adverse Effect Level’ (NOAEL) for systemic toxicity was therefore considered to be 1000 mg/kg bw/day.




Executive summary:

The repeated dose toxicity of the test item 9-dodecenoic acid, methyl ester via the oral route has been read-across from the substance 9-decenoic acid, methyl ester from the following study:


A 28 day repeat dose oral toxicity study combined with a reproduction/ developmental toxicity screening test of the test item was performed in the Wistar rat, according to OECD Guideline 422, in compliance with GLP. The test item, 9-decenoic acid, methyl ester was administered by gavage to three groups, each of ten male and ten female Wistar Han™:RccHan™:WIST strain rats, for up to eight weeks (including a two week pre-pairing phase, pairing, gestation and early lactation for females), at dose levels of 30, 300 and 1000 mg/kg bw/day. A control group of ten males and ten females was dosed with vehicle alone (Arachis oil BP).
Clinical signs, behavioural assessments, body weight change, food and water consumption were monitored during the study. All animals were subjected to a gross necropsy examination and histopathological evaluation of selected tissues was performed.
The oral administration of 9-decenoic acid, methyl ester (9DAME) to rats by gavage did not result in any toxicologically significant effects. The ‘No Observed Adverse Effect Level’ (NOAEL) for systemic toxicity was therefore considered to be 1000 mg/kg bw/day (Harlan Laboratories Ltd, 2012). Based on the results of the read across study, similar NO(A)Els can be expected for the test item.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

To assess repeated dose toxicity an experiment result has been read-across from a supporting substance, structural analogue 9-decanoic acid, methyl ester (EC 662-772-0):


 


Repeat dose oral toxicity:


A 28 day repeat dose oral toxicity study combined with a reproduction/ developmental toxicity screening test of the test item was performed in the Wistar rat, according to OECD Guideline 422, in compliance with GLP. The test item, 9-decenoic acid, methyl ester was administered by gavage to three groups, each of ten male and ten female Wistar Han™:RccHan™:WIST strain rats, for up to eight weeks (including a two week pre-pairing phase, pairing, gestation and early lactation for females), at dose levels of 30, 300 and 1000 mg/kg bw/day. A control group of ten males and ten females was dosed with vehicle alone (Arachis oil BP).
Clinical signs, behavioural assessments, body weight change, food and water consumption were monitored during the study. All animals were subjected to a gross necropsy examination and histopathological evaluation of selected tissues was performed.
The oral administration of 9-decenoic acid, methyl ester (9DAME) to rats by gavage did not result in any toxicologically significant effects. The ‘No Observed Adverse Effect Level’ (NOAEL) for systemic toxicity was therefore considered to be 1000 mg/kg bw/day (Harlan Laboratories Ltd, 2012). Based on the results of the read across study, similar NO(A)Els can be expected for the test item.

Justification for classification or non-classification

In an OECD 422 study conducted on a structural analogue substance, the oral administration of the test item to rats by gavage, at dose levels up to 1000 mg/kg bw/day, did not result in any toxicologically significant effects and the NOAEL for systemic toxicity considered as 1000 mg/kg bw/day.

Classification for STOT-RE is not justified according to the criteria described in Regulation (EC) No 1272/2008.