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EC number: 203-306-4 | CAS number: 105-54-4
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
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- Toxicological Summary
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- Specific investigations
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- Additional toxicological data

Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from a peer-reviewed journal.
Data source
Reference
- Reference Type:
- publication
- Title:
- Evaluation of the Teratogenic Potential of Octyl Acetate in Rats
- Author:
- W. C. DAUGHTREY, P. J. WIER,1 K. A. TRAUL,2 R. W. BILES, AND G. F. EGAN
- Year:
- 1 989
- Bibliographic source:
- Fundamental and Applied Toxicology, 13, 303-309 (1989)
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- Teratogenic potential toxicity study of test chemical was performed in rats.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Octyl acetate
- EC Number:
- 203-939-6
- EC Name:
- Octyl acetate
- Cas Number:
- 112-14-1
- Molecular formula:
- C10H20O2
- IUPAC Name:
- octyl acetate
- Details on test material:
- - Name of test material (as cited in study report):Acetate C-8
- Molecular formula:C10H20O2
- Molecular weight :172.266 g/mole
- Substance type:Organic
- Physical state:Liquid
- Impurities (identity and concentrations):No data available
Constituent 1
- Specific details on test material used for the study:
- - Molecular formula:C10H20O2
- Molecular weight :172.266 g/mole
- Substance type:Organic
- Physical state:Liquid
- Impurities (identity and concentrations):No data available
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories
- Age at study initiation: (P) x wks; 9 weeks old
- Weight at study initiation: 212 - 216 g female
- Fasting period before study: No data available
- Housing: Animals were housed individually (except during the first week of quarantine and during mating) in suspended stainless-steel cages and All animals were identified by uniquely numbered ear tags during the course of the study.
- Diet (e.g. ad libitum): Food (certified Rodent Chow, Ralston Punna Co.)
- Water (e.g. ad libitum): water, ad libitum
- Acclimation period: 3-week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19- 24 °C (monitored daily)
- Humidity (%): 40-70% (monitored daily)
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): 12-hr photoperiod
IN-LIFE DATES: From: To: No data available
Administration / exposure
- Route of administration:
- oral: gavage
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- water
- Remarks:
- Distilled
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Test chemical was dissolved in distilled water to give as dose of 0, 100, 500 or 1000 mg/Kg
DIET PREPARATION:
- Rate of preparation of diet (frequency): No data
- Mixing appropriate amounts with (Type of food): No data
- Storage temperature of food: No data
VEHICLE:
- Justification for use and choice of vehicle (if other than water): Distilled water
- Concentration in vehicle: 0, 100, 500 or 1000 mg/Kg
- Amount of vehicle (if gavage): Dose volumes were based on GD 6 body weights throughout the dosing period
- Lot/batch no. (if required): No data
- Purity: No data - Details on mating procedure:
- - M/F ratio per cage: No data avaialble
- Length of cohabitation: No data avaialble
- Proof of pregnancy: [vaginal plug / sperm in vaginal smear] referred to as [day 0 / day 1] of pregnancy: Copulatory plug in the vagina
or by observation of sperm in a vaginal rinse were referred to as day 0 of pregnancy
- After ... days of unsuccessful pairing replacement of first male by another male with proven fertility. No data avaialble
- Further matings after two unsuccessful attempts: [no / yes (explain)]: No data available
- After successful mating each pregnant female was caged (how): Individually
- Any other deviations from standard protocol: No data avaialble - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No Data Available
- Duration of treatment / exposure:
- 10 days
- Frequency of treatment:
- Daily
- Details on study schedule:
- - Rationale for animal assignment (if not random): Females confirmed to have mated were randomly assigned to one of four experimental groups of 22 mated female rats.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 100, 500 and 1000 mg/Kg
Basis:
- No. of animals per sex per dose:
- Total: 85 Animals
0 mg/kg bw : 22 female
100 mg/kg bw :20 female
500 mg/kg bw :22 female
1000 mg/kg bw :21 female - Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data avaialble
- Positive control:
- No data avaialble
Examinations
- Parental animals: Observations and examinations:
- Survival, clinical sign, body weight and body weight change and food consumption were observed.
- Oestrous cyclicity (parental animals):
- Corpora lutea and Resorptions were examined.
- Sperm parameters (parental animals):
- No data available
- Litter observations:
- Fetuses were weighed and sexed.
- Postmortem examinations (parental animals):
- Organ weight and gross pathology were examined.
- Postmortem examinations (offspring):
- Examined externally for gross abnormalities, visceral, and skeletal malformations and variations, and crown-rump distance were measured.
- Statistics:
- Maternal body weight and body weight change, food consumption, uterine data (i.e., corpora lutea, implants, resorptions), and malformation data were analyzed statistically using Bartlett's test of homogeneity of variance (Snedecor and Cochran, 1967) was used to determine if the groups had equivalent variances at the 1 % level of significance. If the variances were not significantly different, the groups were compared using a standard one-way analysis of variance (ANOVA). If significant differences among the means were indicated, Duncan's test (Dunnett, 1964) was performed to determine which treated groups differed from control. Fetal weights and crown-rump lengths were analyzed using individual fetal values by a standard nested analysis of variance, with values nested within dams and dams nested within groups. If differences in groups were indicated, the least-significantdifference technique (Snedecor and Cochran, 1967) was used to determine which treated groups differed from control. If the groups did not have equivalent variances at the 1 % level, then a Kruskal-Wallis test (nonparametric) was used to assess differences in group means (Hollander and Wolf, 1973). If the means were different, a rank sum comparison was used to determine which treatment groups differed from control.
- Reproductive indices:
- No data avaialble
- Offspring viability indices:
- No data avaialble
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- When treated with 1000 mg/kg bw, elevated incidences of alopecia, rales, red nasal discharge, and anal-genital staining were observed in treated female rats as compared to control.
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- When treated with 1000 mg/kg bw, 2 female rats were died one each on GDs 10 and 12, respectively. No effect on mortality of 100 and 500 mg/kg bw treated female rats were observed as compared to control.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- When treated with 1000 mg/kg bw, a statistically significant decreased in mean body weight on on GDs 9, 12, 16, and 20 were observed as compared with control. The effect was most evident during the first several days of dosing, when these animals actually lost weight (GDs 6-9). When treated with 500 mg/kg bw, Statistically significant decrase in mean body weight and body weight changes were observed at several time points as compared with control. These decrase in body weight appeared to occur in an ordered response to dose.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- When treated with 500 and 1000 mg/kg bw, dose-related decreases in food consumption for the Day 6-9, 9-12, and 12- 16 intervals were observed as compared with control.
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- When treated with 1000 mg/kg bw, slight increase in resorptions were observed as compared to control. But, the difference was not statistically significant. No statistically significant effect was observed on Corpora lutea/dam, Implants/litter, Resorptions/litter and Live fetuses/litter as compared to control.
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- clinical signs
- mortality
- body weight and weight gain
- food consumption and compound intake
- Remarks on result:
- other:
Target system / organ toxicity (P0)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- no mortality observed
- Description (incidence and severity):
- Mortality: No significant effect was observed on Live fetuses/litter s compared to control.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- Body weight:
No significant effect was observed on fetal body weight as compared to control. - Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Gross pathology:
Tail absent were observed in 1000 mg/kg bw and micrognathia in 500 mg/kg bw as compared to control. No significant differences or dose-related change were observed on crown rump distance of fetuses were observed as compared to control. - Histopathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Histopathology:
Visceral examinations:
When treated wtih 1000 mg/kg bw, dilated lateral cerebral ventricles in two fetuses were observed which are anatomical variations previously observed in historical control fetuses.
Skeletal malformations:
When treated wtih 1000 mg/kg bw, Different types of vertebral malformations were observed in four fetuses (four litters) in the form of incomplete ossification but, was not statistically significant as compated to control. - Other effects:
- not specified
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not specified
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No effect on body weight, gross pathology and histopathology
- Remarks on result:
- other: No developmental toxic effects were observed
Target system / organ toxicity (F1)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
- Treatment related:
- not specified
Any other information on results incl. tables
Maternal Body Weight And Body Weight Changesa
|
Dose group |
|||
Gestational day |
0 g/kg (N=20) |
0.1 g/kg (N=20) |
0.5 g/kg (N=20) |
1. 0 g/kg (N=20) |
|
Body weight (g) |
|||
0 |
216.7 ±22.5 |
214.8 ± 16.0 |
213.7 ± 18.3 |
212.0± 18.5 |
3 |
233.3 ±22.4 |
232.0 ±17.2 |
230.1 ± 17.8 |
227.9 ±19.2 |
6 |
248.8 ± 23.0 |
246.1 ±17.8 |
244.6 ± 20.0 |
242.9 ± 20.2 |
9 |
261.0 ±24.9 |
256.6 ±18.4 |
247.3 ±21.2 |
234.7 ±24.5** |
12 |
279.9 ± 24.3 |
273.7 ±19.9 |
261.1 ±23.4* |
247.0 ±25.4" |
16 |
306.5 ± 26.0 |
300.0 ±23.5 |
288.0 ±27.1 |
275.3 ± 24.7** |
20 |
368.5 ±28.0 |
361.3 ±27.7 |
352.4 ±34.9 |
338.1 ±26.7* |
20c |
295.3 ±23.0 |
285.6 ±21.1 |
272.1 ±26.0* |
265.1 ±24.3** |
|
Body weight change (g) |
|||
0-6 |
32.0 ± 3.8 |
31.3 ± 4.8 |
30.9 ± 6.8 |
30.9 ± 6.0 |
6-9 |
12.2 ± 4.1 |
10.6 ± 5.1 |
2.7 ± 11.3** |
-8.1 ± 12.1** |
9-12 |
18.9 ± 4.2 |
17.1 ± 4.1 |
13.8 ± 9.4* |
13.5 ± 7.9* |
12-16 |
26.6 ± 6.9 |
26.3 ± 5.6 |
26.9 ± 8.6 |
27.3 ± 8.5 |
16-20 |
62.0 ± 6.6 |
61.3 ± 9.0 |
64.4 ± 10.8 |
62.8 ± 5.5 |
0-20 |
151.8 ± 13.9 |
146.5 ± 16.4 |
138.6 ±25.9 |
126.3 ± 15.5** |
6-20c |
46.6 ± 8.5 |
39.6 ± 9.6 |
28.8 ±15.0** |
22.2 ± 13.3** |
aValues are means ± SD. N = number of dams.
b From Day 12, W =20; from Day 16, N= 19.
c Body weight corrected for gravid uterine weight.
* Significantly different from control, p≤0.05.
** Significantly different from control, p≤0.01.
Mean food consumption of pregnant ratsa
|
Dose group |
|||
Gestational day |
0 g/kg
|
0.1 g/kg
|
0.5 g/kg
|
1.0 g/kg
|
0-3 |
69.2+ 5.9 |
69.8 ± 5.6 |
69.2+ 5.7 |
67.6 ± 5.7 |
|
(21)* |
(19) |
(22) |
(21) |
3-6 |
76.4+ 6.8 |
72.3 ± 7.8 |
73.3 ± 6.2 |
72.5 ± 5.7 |
|
(20) |
(18) |
(22) |
(21) |
6-9 |
76.7 ± 8.1 |
72.8 ± 7.2 |
63.7 ± 11.1" |
49.3 ±12.3** |
|
(22) |
(19) |
(22) |
(21) |
9-12 |
80.7 ± 7.5 |
75.5 ± 8.5 |
66.9 ± 9.4" |
60.5 ± 19.2" |
|
(21) |
(H) |
(21) |
(18) |
12-16 |
104.3 ± 10.5 |
101.8 ± 11.9 |
92.4+ 13.2* |
88.8 ± 9.4" |
|
(22) |
(19) |
(19) |
(19) |
16-20 |
112.7 db 8.5 |
111.9± 11.6 |
109.8 ± 14.0 |
110.0 ± 10.9 |
|
(22) |
(20) |
(22) |
(19) |
|
|
|
|
|
aValues are the means ± SD of the amount of diet consumed expressed in grams per rat.
* N is given in parentheses.
* Significantly different from control, p≤ 0.05.
** Significantly different from control, p≤0.01.
Uterine Implantation Dataa
|
Dose group |
|||
|
0 g/kg (N=20) |
0.1 g/Kg (N = 20) |
0.5 g/kg (N=20) |
1.0 g/kg (N =20) |
Corpora lutea/dam |
16.0 ± 1.6 |
15.9 ± 2.2 |
16.1 ± 2.5 |
16.5 ±2.6 |
Implants/litter |
14.7 ± 1.5 |
14.7 ± 2.0 |
14.9 ± 2.1 |
14.8 ± 1.9 |
Resorptions/litter |
0.6 ±0.7 |
0.9 ± 1.2 |
0.6 ± 0.8 |
1.3± 1.4 |
Uterine weight (g) |
74.9 ± 9.0 |
75.6 ±12.1 |
77.8± 13.1 |
73.0 ±8.8 |
Live fetuses/litter |
7.9 ± 1.9 |
7.4 ± 1.8 |
7.0 ± 1.8 |
6.7 ±2.2 |
Male |
6.2 ±1.6 |
6.3 ± 1.8 |
7.2 ± 1.6 |
6.8 ± 1.9 |
Female |
14.1 ± 1.6 |
13.7 ± 2.2 |
14.2 ± 2.0 |
13.5 ± 1.7 |
Total |
16.0 ± 1.6 |
15.9 ± 2.2 |
16.1 ± 2.5 |
16.5 ±2.6 |
aValues are means ± SD. N = number of litters.
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 500 mg/kg bw for P generation and 1000 mg/kg bw for F1 generation when Sprague-Dawley female rats were treated with the test chemical orally by gavage for 10 days of gestation.
- Executive summary:
In a teratogenicity study, Sprague-Dawley female rats were treated with test chemical of Octyl acetate (Cas 112-14-1)in the concentration of 0, 100, 500 and 1000 mg/kg/bw/day orally by gavage. Two female rats died in the 1000 mg/kg one each on GDs 10 and 12, respectively. Also, maternal animals in the high-dose group exhibited elevated incidences of alopecia, rales, red nasal discharge and anal-genital staining. Statistically significant and dose-related decrease in mean body weight, and body weight changes were detected in the 1000 mg/kg groups on GDs 9, 12, 16, and 20 were observed at 1000 mg/kg. The effect was most evident during the first several days of dosing, when these animals actually lost weight (GDs 6-9). Statistically significant decrease in mean body weight and body weight changes were observed at several time points at 500 mg/kg as compared with control. These decrease in body weight appeared to occur in an ordered response to dose. Similarly, dose-related decreases in food consumption on GD 6-9, 9-12, and 12- 16 intervals were observed at 500 and 1000 mg/kg as compared with control. The uterine implantation parameters including corpora lutea/dam, implants/litter, resorptions/litter, uterine weight or live fetuses/litter showed no statistically significant or dose-dependent differences between control and any of the treated-groups. Although, a slight increase in the number of resorptions was detected in the 1000 mg/kg group as compared to control, the difference was not significant.In the F1 generation, there was no significant or dose-dependent effects on embryo-fetal lethality or fetal growth for any treatment group.No significant differences or dose-related change were observed on crown rump distance of fetuses were observed as compared to control.The number of litters of at least one malformed fetus and the mean percentage of the litter malformed were significantly elevated in the high-dose group only. External observation revealed only two malformations: one in the 1000 mg/kg group (tail absent) and one in the 500 mg/kg group (micrognathia). Visceral examinations revealed two fetuses with abnormalities only in two fetuses at 1000 mg/kg. All groups exhibited comparably low incidences of malformations (dilated ureters/distended renal pelvises), which are anatomical variations previously observed in historical control fetuses. Fetuses with skeletal malformations were observed in the control, low-dose and high-dose groups at low incidence. In addition, different types of vertebral malformations were observed in four fetuses (four litters) from the high-dose group,but, were not statistically significant as compared to control.In conclusion, the test chemicalduring GD 6-15 at the dose level of 500 mg/ml and 1000 mg/kg resulted in significant maternal toxicity as evidenced by reduction in body weight, body weight gain and food consumption of pregnant female rats. However, the administration of the test chemical at maternally toxic doses of 500 and 1000 mg/kg had no adverse effect on sexual function, fertility and fetus development. The administration of the test chemicalslightly increased the incidence of fetal malformations in rats at 1000 mg/kg, which was seriously toxic for mothers. However, no developmental toxicity was observed at the maternally toxic dose of 500 mg/kg or the maternally non-toxic dose of 100 mg/kg. Some developmental effects produced only at maternally toxic exposure levels which indicates that Octyl acetateis not a selective developmental toxicant in rat and it does not disrupt development without obvious signs of adult toxicity. Hence, the NOAEL for reproductive and developmental toxicity is estimated as 500 mg/kg/bw/day for P0 (parental) generations and 1000 mg/kg/bw/day for F1 generationwhen Sprague-Dawley female rats were orally treated with Octyl acetate for 10 days of gestation under the certain conditions. Maternal toxicity level is 100 mg/kg/bw/day when pregnant female SD rats are orally dosed with the test chemical during gestation.
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