Resin acids and Rosin acids, esters with diethylene glycol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study conducted according to OECD Guideline 401.

Justification for type of information:

A discussion and report on the read across strategy is given as an attachment in Section 13.

Cross-reference

Reason / purpose for cross-reference:

read-across: supporting information

Reference

Endpoint:

acute toxicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study conducted according to OECD Guideline 401.

Justification for type of information:

A discussion and report on the read across strategy is given as an attachment in Section 13.

Reason / purpose for cross-reference:

read-across source

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality was noted during the study.

Clinical signs:

other: other: Immediately following dosing, excitation and the appearance of piloerection were observed for treated animals. These observations disappeared in the following hours. No abnormal clinical signs were recorded for control animals. Daily examinations f

Gross pathology:

No internal tissue abnormalities were noted at autopsy.

Interpretation of results:

study cannot be used for classification

Conclusions:

Under conditions used in this study, Resin acids and Rosin acids, hydrogenated, Me esters was not lethal by the oral route in male rats at a dose of 2000 mg/kg bw. The oral LD50 in male rats was > 2000 mg/kg bw. Based on an acute oral LD50 value greater than 2000 mg/kg bw in male rats, Resin acids and Rosin acids, hydrogenated, Me esters is not classified for acute lethality by the oral route under EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008. The UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) defines a fifth category for acute toxicity for chemicals with oral LD50 values between 2000 and 5000 mg/kg bw. Insufficient data were available from this study to provide a definitive classification under UN GHS.

Based on the presence of excitation and piloerection in treated animals following dosing indicating reversible effects on the central nervous system, Resin acids and Rosin acids, hydrogenated, Me esters is classified as Category 3 for Specific Target Organ Toxicity–Single Exposure under UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.

Executive summary:

This data is being read across from the source study that tested Resin acids and Rosin acids, hydrogenated, methyl esters based on category read across that is explained in the category justification document attached in Section 13 of the dossier.

In an acute oral toxicity study, a group of five male rats was administered a single dose of Resin acids and Rosin acids, hydrogenated, Me esters by gavage at a dose level of 2000 mg/kg bw. Serving as controls, an additional group of five male rats was administered distilled water at 2.0 mL/kg bw. All rats were observed for mortality and adverse clinical signs for a period of 14 days. No mortality was noted in either treated or control animals. Immediately following dosing of the test substance, excitation and the appearance of piloerection were observed. These observations disappeared over the following hours. No abnormal clinical signs were recorded for control animals. Daily examinations for 14 days following treatment showed no changes in the state or behavior of the animals. All treated and control animals gained weight over the course of the study. At necropsy, no gross lesions were observed. The oral LD50 in male rats is considered to be greater than 2000 mg/kg bw. Based on the results of this study, Resin acids and Rosin acids, hydrogenated, Me esters is considered to be a low toxicity hazard upon ingestion.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Remarks:

Laboratory Accreditation: RNE No. 29-85/1/26 (no certificate available)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Resin acids and Rosin acids, hydrogenated, Me esters

EC Number:

232-476-2

EC Name:

Resin acids and Rosin acids, hydrogenated, Me esters

Cas Number:

8050-15-5

Molecular formula:

Not applicable for UVCB constituents

IUPAC Name:

Resin acids and Rosin acids, hydrogenated, Me esters

Details on test material:

-Name (according to study report): HYDROGRAL M
-Laboratory petition: 410209
-Density: 0.99
-Appearance: thick liquid of yellow color with pleasant odor
-Storage: at ambient temperature in the absence of light
-Date test material received: 1989-10-16
-Registration reference: 0397

Test animals

Species:

rat

Strain:

not specified

Sex:

male

Details on test animals or test system and environmental conditions:

-Source: IFFA CREDO installe a 69210 L'abresle
-Sex: males
-Average weight at study initiation: 305.2 g (control group); 307.2 g (test group)
-Housing conditions: 5/cage/group
-Conforms to test conditions described in directive 86/609/CEE.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Test material was administered as received. Each animal received a single dose of the test material by oral gavage.

Doses:

0 and 2000 mg/kg bw

No. of animals per sex per dose:

5 males/dose group

Control animals:

yes

Details on study design:

Rats were fasted for 18 hours, receiving only water. The test substance was administered orally to five male rats at a dose of 2000 mg/kg bw (2.02 mL/kg bw) per rat. Five additional male rats served as controls. Control rats received distilled water at a dose of 2 mL/kg bw. Body weights were recorded on Days -2, 0, 3, 7, and 14. Rats were observed for 14 days following treatment. After termination of the observation period, all rats were necropsied and examined for lesions.

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality was noted during the study.

Clinical signs:

other: other: Immediately following dosing, excitation and the appearance of piloerection were observed for treated animals. These observations disappeared in the following hours. No abnormal clinical signs were recorded for control animals. Daily examinations f

Gross pathology:

No internal tissue abnormalities were noted at autopsy.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

Under conditions used in this study, Resin acids and Rosin acids, hydrogenated, Me esters was not lethal by the oral route in male rats at a dose of 2000 mg/kg bw. The oral LD50 in male rats was > 2000 mg/kg bw. Based on an acute oral LD50 value greater than 2000 mg/kg bw in male rats, Resin acids and Rosin acids, hydrogenated, Me esters is not classified for acute lethality by the oral route under EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008. The UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) defines a fifth category for acute toxicity for chemicals with oral LD50 values between 2000 and 5000 mg/kg bw. Insufficient data were available from this study to provide a definitive classification under UN GHS.

Based on the presence of excitation and piloerection in treated animals following dosing indicating reversible effects on the central nervous system, Resin acids and Rosin acids, hydrogenated, Me esters is classified as Category 3 for Specific Target Organ Toxicity–Single Exposure under UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.

Executive summary:

In an acute oral toxicity study, a group of five male rats was administered a single dose of Resin acids and Rosin acids, hydrogenated, Me esters by gavage at a dose level of 2000 mg/kg bw. Serving as controls, an additional group of five male rats was administered distilled water at 2.0 mL/kg bw. All rats were observed for mortality and adverse clinical signs for a period of 14 days. No mortality was noted in either treated or control animals. Immediately following dosing of the test substance, excitation and the appearance of piloerection were observed. These observations disappeared over the following hours. No abnormal clinical signs were recorded for control animals. Daily examinations for 14 days following treatment showed no changes in the state or behavior of the animals. All treated and control animals gained weight over the course of the study. At necropsy, no gross lesions were observed. The oral LD50 in male rats is considered to be greater than 2000 mg/kg bw. Based on the results of this study, Resin acids and Rosin acids, hydrogenated, Me esters is considered to be a low toxicity hazard upon ingestion.