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Administrative data

Description of key information

Acute toxicity - oral route: LD50 > 2000 mg/kg bw (OECD 423, GLP, K, rel.1)

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:
18 August 2017 - 02 November 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Study performed according to OECD test guideline No. 423 and in compliance with GLP.
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
17 December 2001
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. QA statement)
Remarks:
French GLP Compliance Programme for chemical products (inspected on 30-31 January 2017 / signed on 27 April 2017)
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Elevage JANVIER LABS
- Females nulliparous and non-pregnant: Yes
- Age at study initiation: 8 weeks old
- Weight at study initiation: 189 - 214 g
- Fasting period before study: Not specified
- Housing: Healthy female rats were housed by group of three in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid. Each cage contains sawdust bedding which was changed at least 2 times a week. Each cage was installed in conventional air conditioned animal husbandry.
- Diet (e.g. ad libitum): Foodstuff (ENVIGO - 2016) ad libitum. Food was removed on day 1 and then redistributed 4 hours after the test item administration.
- Water (e.g. ad libitum): Drinking water (tap-water from public distribution system) ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25°C
- Humidity (%): 30 - 70%
- Air changes (per hr): At least ten changes per hour
- Photoperiod (hrs dark / hrs light): 12h dark / 12h light

IN-LIFE DATES: From: 29 August 2017 To: 13 September 2017
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
VEHICLE: Not applicable

MAXIMUM DOSE VOLUME APPLIED: 1.93 mL/kg body weight (corresponding to 2 g/kg, according to the calculated density)

DOSAGE PREPARATION: Not applicable. The test item was used as supplied in the study.

CLASS METHOD
- Rationale for the selection of the starting dose: The experimental protocol was established according to the official method as defined in the OECD guideline No. 423 dated December 17th, 2001 and the test method B.1tris of the Council regulation No. 440/2008.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6 females/dose (3 females for the Step 1 and 3 females for the Step 2)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days.
- Frequency of observations: Systematic examinations were carried out daily to identify any behavioural or toxic effects on the major physiological functions 30 min, 1h, 3h, 4h, 24h, 48h after administration of the test item and continued daily during 14 days. Clinical observations and mortality were recorded every day for 14 days.
- Frequency of weighing: D0 (just before administering the test item) then on D2, D7, and D14.
- Necropsy of survivors performed: Yes; On day 14, the animals were euthanized with sodium pentobarbital (Dolethal®).
- Other examinations performed: Macroscopic observations were entered on individual autopsy sheets. Only those organs likely to be modified in cases of acute toxicity were examined. Those presenting macroscopic anomalies can be removed and preserved in view to microscopic examinations.
Statistics:
None
Preliminary study:
Not applicable
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality occurred during the study.
Mortality:
No mortality occurred during the study.
Clinical signs:
other: No clinical signs related to the administration of the test item were observed during the study.
Gross pathology:
The macroscopic examination of the animals at the end of the study did not reveal treatment related changes.
Other findings:
None

None

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, the oral LD50 of the test substance, Dimethyl Pimelate, is higher than 2000 mg/kg bw in female rats. In accordance with the OECD guideline No. 423, the LD50 cut-off of the test item may be considered to be higher than 5000 mg/kg body weight by oral route in the rat. Therefore, the test substance, Dimethyl Pimelate, is not classified for acute oral toxicity according to the criteria of the Annex VI of the Regulation (EC) N°1272/2008 (CLP) and to the GHS. Furtheremore, the absence of adverse effect is consistent with this classification.
Executive summary:

An acute oral toxicity study was performed according to OECD Guideline No. 423 and EU Method B.1 tris (acute toxic class method) and in compliance with GLP.

One group of three female Sprague Dawley rats received a single oral gavage dose of the test substance at a dose level of 2000 mg/kg bw. As results at this dose level indicated the acute lethal oral dose of the test substance to be greater than 2000 mg/kg bw, in compliance with the study guidelines, a further group of three females was similarly dosed at 2000 mg/kg bw to complete the study. Animals were then observed for mortality, clinical signs and body weights for 14 days and were all sacrificed for macroscopic examination.

There were no deaths during the study. No clinical signs related to the administration of the test item were observed during the study. The body weight evolution of the animals remained normal throughout the study. The macroscopic examination of the animals at the end of the study did not reveal treatment related changes.

Under the test conditions, the oral LD50 of the test substance, Dimethyl Pimelate, is higher than 2000 mg/kg bw in female rats. In accordance with the OECD guideline No. 423, the LD50 cut-off of the test item may be considered to be higher than 5000 mg/kg body weight by oral route in the rat. Therefore, the test substance, Dimethyl Pimelate, is not classified for acute oral toxicity according to the criteria of the Annex VI of the Regulation (EC) N°1272/2008 (CLP) and to the GHS. Furtheremore, the absence of adverse effect is consistent with this classification.

This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acute oral toxicity

One key study was identified for the acute toxicity via oral route.

A key study (Richeux, 2018, Rel. 1) was performed to assess the acute toxicity of the test substance after oral administration. This standard acute oral toxicity study was performed according to the OECD Guideline No. 423 and EU Method B.1tris (acute toxic class method) under GLP compliance.

One group of three female Sprague Dawley rats received a single oral gavage dose of the test substance at a dose level of 2000 mg/kg bw. As results at this dose level indicated the acute lethal oral dose of the test substance to be greater than 2000 mg/kg bw, in compliance with the study guidelines, a further group of three females was similarly dosed at 2000 mg/kg bw to complete the study. Animals were then observed for mortality, clinical signs and body weights for 14 days and were all sacrificed for macroscopic examination.

There were no deaths during the study. No clinical signs related to the administration of the test item were observed during the study. The body weight evolution of the animals remained normal throughout the study. The macroscopic examination of the animals at the end of the study did not reveal treatment related changes.

Under the test conditions, the oral LD50 of the test substance, Dimethyl Pimelate, is higher than 2000 mg/kg bw in female rats. In accordance with the OECD guideline No. 423, the LD50 cut-off of the test item may be considered to be higher than 5000 mg/kg body weight by oral route in the rat. Therefore, the test substance, Dimethyl Pimelate, is not classified for acute oral toxicity according to the criteria of the Annex VI of the Regulation (EC) N°1272/2008 (CLP) and to the GHS. Furtheremore, the absence of adverse effect is consistent with this classification.

This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.

Justification for classification or non-classification

Harmonized classification:

Dimethyl Pimelate does not have an harmonized classification according to the Regulation (EC) No. 1272/2008.

Self-classification:

Acute toxicity (oral):

Based on the available information, the substance is:

- not classified according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) as the oral LD50 is higher than 2000 mg/kg bw

- not classified according to the GHS since there is no reliable evidence that indicates the LD50 to be in the range of Category 5 values (GHS criteria not met).

Specific target organ toxicity: single exposure (Oral):

The classification criteria according to the Annex VI of the Regulation (EC) No. 1272/2008 as specific target organ toxicant (STOT) – single exposure, oral are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure and no effects were observed at the guidance value (oral) for a Category 1 classification (C≤ 300 mg/kg bw) and at the guidance value (oral) for a Category 2 classification (2000 mg/kg bw≥ C > 300 mg/kg bw). No classification is required.

The criteria for Transient Organ effects (STOT-SE Category 3) according to Annex VI of the Regulation (EC) No. 1272/2008 are not met since narcotic effects were not observed in the acute oral toxicity study.