1-methylheptyl acrylate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

8 august 2017 - 23 august 2017

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

17 December 2001

Deviations:

yes

Remarks:

Due to technical reason, temperature values (maximum of 25.6°C) out of the target range 19-25°C were observed.These minor differences in the environmental parameter were considered not to adversely affect the study.

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1-methylheptyl acrylate

EC Number:

256-005-5

EC Name:

1-methylheptyl acrylate

Cas Number:

42928-85-8

Molecular formula:

C11H20O2

IUPAC Name:

octan-2-yl prop-2-enoate

Test material form:

liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: breeder: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, D-97633 Sulzfeld, Germany
- Age at study initiation: approximately 8 weeks old on the day of treatment
- Mean body weight at study initiation: 182 – 193 g
- Fasting period before study: yes, during the night before treatment
- Housing: the animals were housed by three from the same group in Type II polypropylene/polycarbonate cages
- Diet: SSNIFF SM R/M; ssniff Spezialdiäten GmbH, D-59494 Soest, Germany(free access)
- Water: tap water filtered from the municipal supply (free access)
- Acclimation period: at least 5 days before the beginning of the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.8 – 25.6°C
- Humidity (%): 34 – 70%
- Air changes (per hr): approximately 15 - 20 air exchanges /hour
- Photoperiod (hrs dark / hrs light): 12 h/12 h

IN-LIFE DATES: 3 august 2017 to 23 august 2017

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Remarks:

Lot number: A0384372, Producers: Acros Organics, Belgium

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL
- Justification for choice of vehicle: the test substance is an ester which hydrolyses in aqueous media, therefore corn oil was used as a vehicle during the study.. A homogenous suspension was obtained in corn oil at the concentration of 200 mg/mL.

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw.

DOSAGE PREPARATION (if unusual): Dose formulations were prepared based on weight on the day of administration and kept under magnetic stirring up to the end of dose administration procedure.

CLASS METHOD (if applicable):
- Rationale for the selection of the starting dose: Limit dose of 2000 mg/kg bw was selected as a starting dose as it was the dose which was most likely to produce mortality in some of the dosed animals.

Doses:

2000 mg/kg b.w.

No. of animals per sex per dose:

3 females per treatment step

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Clinical observations: at 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter.
- Body weight: just before treatment, then on day of treatment (day 0) and on days 7 and 14.
- Necropsy of survivors performed: yes

Statistics:

no

Results and discussion

Preliminary study:

Not applicable

Effect levels

Key result

Sex:

female

Dose descriptor:

LD0

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed at dose level of 2000 mg/kg bw.

Clinical signs:

other: All animals showed decreased activity (score 1 or 2, Day 0), hunched back (Day 0 and 1) and incoordination (score 1 or 2, Day 0). In addition, piloerection was observed in 1 out of 6 animals on Day 0. From Day 2 all animals were symptom-free.

Gross pathology:

The test item administration did not induce any macroscopic findings at necropsy.

Other findings:

no

Any other information on results incl. tables

Table 7.2.2/1: Signs associated with dosing -Individual observations on Days 1and 2

Cage number	Animal number	Observations	Observation days
			0						1	2
			30’	1h	2h	3h	4h	6h
1	368	Symptom Free	+	-	-	-	-	-	-	+
		Activity decreased	-	-	1	1	1	2	-	-
		Hunched back	-	+	+	+	+	+	+	-
		Incoordination	-	-	-	-	2	2	-	-
	369	Symptom Free	+	-	-	-	-	-	-	+
		Activity decreased	-	-	1	1	1	2	-	-
		Hunched back	-	+	+	+	+	+	+	-
		Incoordination	-	-	-	-	1	1	-	-
	370	Symptom Free	+	-	-	-	-	-	-	+
		Activity decreased	-	-	1	1	1	1	-	-
		Hunched back	-	+	+	+	+	+	+	-
		Incoordination	-	-	-	-	1	1	-	-
2	371	Symptom Free	+	+	-	-	-	-	-	+
		Activity decreased	-	-	-	1	1	1	-	-
		Hunched back	-	-	+	+	+	+	+	-
		Incoordination	-	-	-	1	1	1	-	-
	372	Symptom Free	+	-	-	-	-	-	-	+
		Activity decreased	-	-	-	1	1	2	-	-
		Hunched back	-	+	+	+	+	+	+	-
		Incoordination	-	-	1	1	2	2	-	-
		Piloerection	-	-	-	-	-	+	-	-
	373	Symptom Free	+	-	-	-	-	-	-	+
		Activity decreased	-	-	-	1	1	2	-	-
		Hunched back	-	+	+	+	+	+	+	-
		Incoordination	-	-	-	1	1	2	-	-

 + = present                             - = absent

h = hours                                ‘ = minutes

Severities : 1 = slight/small/few, 2= moderate/medium, 3= marked, large, many

 

 

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

No mortalities were observed in rats receiving 2000 mg/kg b.w. but significant reversible clinical signs of toxicity occured.
The substance is not classified according to Regulation (EC) No. 1272/2008 and its subsequent amendments on classification, labeling and packaging (CLP) of substances and mixtures.
According to the Globally Harmonized Classification System (GHS; UNITED NATIONS), the substance is classified as Category 5.

Executive summary:

The substance was tested for acute oral toxicity according to OECD 423 guideline and in compliance with Good Laboratory Practices.

The test item was administered once by gavage to 2 groups of 3 fasted female rats under a dosage-volume of 10 mL/kg. Initially, 3 females (Group 1) were treated at a dose level of 2000 mg/kg bw. As no mortality was observed, a confirmatory group of 3 females was treated at the same dose level. As no mortality was observed in the confirmatory group, no further testing was done.

Clinical observations were performed at 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter. Body weight was recorded before treatment then on day 0, 7 and 14. On completion of the observation period, the animals were sacrificed and then submitted for a macroscopic post-mortem examination.

No unscheduled deaths occurred during the study. On the day of administration (day 0), All animals showed slight or moderate decreased activity, slight or moderate incoordination and hunched posture , this latter being present up to day 1. In addition, piloerection was observed in 1 out of 6 animals. From Day 2 all animals were symptom-free.

Body weight and body weight gain were unaffected by the test item treatment and no macroscopic findings were found at necropsy.

The acute oral LD0 of the test item was equal or higher than 2000 mg/kg bw.