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Toxicological information

Acute Toxicity: oral

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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:
read-across: supporting information
Reference
Endpoint:
acute toxicity: oral
Type of information:
read-across based on grouping of substances (category approach)
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:
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:
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 for 14 days following treatment showed no changes in the state or behavior of the animals.
Body weight:
All treated and control animals gained weight over the course of the study. Mean weight gains were 103.6 g for the treated group and 104.8 g for the control group.
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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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:
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 for 14 days following treatment showed no changes in the state or behavior of the animals.
Body weight:
All treated and control animals gained weight over the course of the study. Mean weight gains were 103.6 g for the treated group and 104.8 g for the control group.
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.