Hydrocarbons, C18-C22, n-alkanes, n-alkenes

Endpoint summary

Description of key information

Both the oral and dermal toxicity of the registered substance were determined to be greater than 2000 mg.kg bw.  As such, the registered substance is not considered classifiable for acute toxicity according to the EC regulations 1272/2008 and subsequent regulations on classification, labelling and packaging of substances and mixtures.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

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

Adequacy of study:

key study

Justification for type of information:

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

Reason / purpose for cross-reference:

read-across source

Preliminary study:

There was no mortality during the study. The estimated acute oral LD50, as indicated by the data, was determined to be greater than 2000 mg/kg.

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There was no mortality during the study.

Clinical signs:

other: All animals appeared normal for the duration of the study.

Gross pathology:

The gross necropsy conducted at termination of the study revealed no observable abnormalities.

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

The test substance was evaluated for its acute oral toxicity potential when administered to albino rats. The acute oral LD50 is estimated to be greater than 2000 mg/kg in females.

Executive summary:

The test substance was evaluated for its acute oral toxicity potential in female albino rats when administered as a gavage dose at a level of 2000 mg/kg. The study was terminated following the stopping rules of this procedure. No mortality occurred during the study. There were no clinical signs of toxicity during the study. There was no effect on body weight gain. The gross necropsy conducted at termination of the study revealed no observable abnormalities. The acute oral LD50 was estimated to be greater than 2000 mg/kg.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

This study is a guideline study with a Klimisch score of 1 (reliable withiout restriction)

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

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

Adequacy of study:

key study

Justification for type of information:

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

Reason / purpose for cross-reference:

read-across source

Preliminary study:

The clinical signs observed consisted of very slight erythema, for the first 4 days post unwrapping. All animals gained body weight. No gross findings were observed during necropsy on any of the 3 animals

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

none

Clinical signs:

other: The abnormal clinical signs observed during the 14-day observation period were limited to erythema of the skin at the site of application. All males exhibited very slight erythema (score 1) from Day 2 to Day 3. Very slight erythema (score 1) was still obs

Gross pathology:

All animals were sacrificed at the end of the study and full gross necropsies were performed. No gross pathological findings were observed
at necropsy.

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

Under the conditions used in this study, the source substance was not lethal by the dermal route of administration in male and female rats at a dose level of 2000 mg/kg. The test compound did not exhibit any systemic toxic effect, and no specific organs for toxicity were identified. The test item was slightly irritating to the exposed skin, however the irritation was reversible. Based on the above findings, Acute Dermal LD50 in Rats of the test item, the source substance, was estimated to be greater than 2000 mg/kg body weight.

Executive summary:

This acute dermal toxicity study of the test item, HF-1000 Solvent (the source substance), was carried out by Nucro-Technics according to Study Plan No. INT/296963.

A limit test was performed on 5 male and 5 female Sprague-Dawley rats. Animals received the test item at a dose volume of 2.51 mL/kg by dermal application at a dose level of 2000 mg/kg. The dose volumes of the test item were individually calculated for each animal based on the body weight of the animal. The calculated dose portion of the test item was placed on the shaved skin of the rat. A 2-ply gauze sheet was applied over the treated area, then the trunk of the rat was wrapped by a semi-occlusive, self-adherent wrap and secured at the ends with adhesive tape. Animals were exposed to the test item for a 24-hour period. At the end of this period, the wrappings were removed and the skin was cleansed by rinsing with sterile Water for Injection USP.

Animals were observed closely for the first 72 hours following dosing, then twice daily for a 14-day observation period for mortality and adverse clinical signs. Skin irritation (erythema and oedema) was recorded daily using the Draize scoring system. At the end of the study, all animals were sacrificed and submitted for gross necropsy.

The abnormal clinical signs were limited to minimal skin irritation. All 10 animals exhibited very slight erythema after wrap removal, from Day 2 to Day 4 for males and from Day 2 to Day 3 for females. By Day 5 for males and Day 4 for females, all signs of erythema had cleared.

Body weights of the animals were determined prior to test item administration, on Day 8 and again on Day 15. All animals gained body weight by Day 8 and also by the end of the study period.

At necropsy, no gross pathological lesions were observed.

Under the conditions used in this study, HF-1000 Solvent (the source substance) was not lethal by the dermal route of administration in male and female rats at a dose level of 2000 mg/kg. The test item did not cause any systemic toxic effect, and no specific organs for toxicity were identified. The test item was slightly irritating to the exposed skin, however the irritation was reversible. Based on the above findings, the Acute Dermal LD50 in rats of the test item, HF-1000 Solvent, was estimated to be greater than 2000 mg/kg body weight.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

The source substance was not lethal by the dermal route of administration in male and female rats at a dose level of 2000 mg/kg. The test item did not cause any systemic toxic effect, and no specific organs for toxicity were identified. The test item was slightly irritating to the exposed skin, however the irritation was reversible.

The source substance was not lethal by the oral route of administration in female rats at a dose level of 2000 mg/kg. The test item did not cause any systemic toxic effect, and no specific organs for toxicity were identified.

No acute toxicity studies by any other route are available for the registered substance.

Justification for selection of acute toxicity – oral endpoint
Only study available which also meets the appropriate test guideline. Note: The actual value of LD50 for this study is greater than 2000 mg/kg bw

Justification for selection of acute toxicity – inhalation endpoint
See waiver for acute inhalation endpoint in section7.2.2.

Justification for selection of acute toxicity – dermal endpoint
Only study available which also meets guidelines. Note: Actual value of LD50 for this study is greater than 2000 mg/kg bw

Justification for classification or non-classification

Based on the results of the oral and dermal studies conducted on the source substance according to the EC regulations 1272/2008 and subsequent regulations on classification, labelling and packaging of substances and mixtures, the registered substance does not require classification.