Paraffin waxes and Hydrocarbon waxes, oxidized, lithium salts

Endpoint summary

Description of key information

ACUTE ORAL TOXICITY
The acute oral toxicity of hydrocarbon waxes was determined to be LD50 > 5000 mg/l according to a GLP compliant study (Gabriel, 1993)

performed according to the standardised guideline 40 CFR Part 798, EPA Health Effects Testing Guidelines - Subpart B - General Toxicity Testing.

ACUTE INHALATION TOXCITY
In accordance with Column 2 (adaptation statement) of Annex VIII of Regulation (EC) 1907/2006 (REACH), the acute dermal toxicity study required under information point 8.5.2 does not need to be conducted as the nature of the substance means that it is not potentially inhalable.

ACUTE DERMAL TOXICITY
In accordance with Section 1 of Annex XI of Regulation (EC) 1907/2006 (REACH), the acute dermal toxicity study required under information point 8.5.3 of Annex VII does not need to be conducted as it is scientifically unjustified.

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:

REPORTING FORMAT FOR THE ANALOGUE APPROACH
see read-across justifocation in section Chapter 13

Reason / purpose for cross-reference:

read-across source

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

- No mortalities were observed within the observation period.

Clinical signs:

other: - All animals appeared normal throughout the study.

Gross pathology:

- No abnormalities were observed in any animal.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the test no mortalities were observed at the dose administered, therefore the LD50 is said to be > 5000 mg/kg, no other signs of systemic toxicity were observed. Thus according to Regulation (EC) 1272/2008 the test material does not require classification.

Executive summary:

In a GLP-compliant study performed following a protocol similar to 40 CFR Part 798 (EPA Health Effects Testing Guidelines - Subpart B - General Toxicity Testing, September 1985), the acute oral toxicity of the test material was determined. Ten male and female rats were exposed to the test material in a limit test at 5000 mg/kg bw, administered in their feed. No mortalities or systemic signs of toxicity were observed within the 14 hour observation period or at necropsy. Therefore it can be said that the LD₅₀ is > 5000 mg/kg, which according to Regulation (EC) 1272/2008 means the test material does not require classification.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Value:

5 000 mg/kg bw

Quality of whole database:

The quality of the database is considered to be high.

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

The key study (Gabriel, 1993) is a GLP compliant study which was performed in line with standardised guidelines with a sufficient level of detail to assess the quality of the study. Ten male and female rats were exposed to the test material in a limit test at 5000 mg/kg bw, administered in their feed. No mortalities or systemic signs of toxicity were observed within the 14 hour observation period or at necropsy, therefore it can be said that the LD₅₀ is > 5000 mg/kg. The study was performed to a good standard and was assigned a reliability score of 2 using the principles for assessing data quality as set out in Klimisch (1997).

Four additional supporting studies have been provided (Winckworth, 1989a-d), all of which are in good agreement with the key study. The test material was administered to Sprague Dawley rats in an acute feeding screening study at 5000 mg/kg bw. Five rats per sex were exposed to the dosed feed ad libitum, for a period of 24 hours. Animals were observed for 14 days post administration, bodyweights were measured at regular intervals and at termination all surviving animals were necropsied.

Under the conditions of the test, animals showed no signs of acute toxicity. No deaths or gross macroscopic changes were observed as a result of exposure, and animals showed normal weight gain. The LD₅₀ of the test material can be said to be greater than 5000 mg/kg bw and the test material is considered to be non-toxic. These are all non-GLP studies, which appear to be performed to sound scientific principles. However they are reported with insufficient detail on the methods and materials to assess the quality of the reported results. The studies have therefore been assigned a reliability score of 4 in accordance with Klimisch (1997).

ACUTE INHALATION TOXCITY

The registered substance has low vapour pressure and therefore is unlikely to be available for inhalation as a vapour. The low water solubility and high molecular weight and log Pow value suggest a limited absorption after inhalation. If any amount of the substance reaches the alveoli, this will be likely phagocytised by macrophages, located into the immune surveillance tissues and broken down in lysosomes and peroxisomes.

ACUTE DERMAL TOXICITY

The physical state, high molecular weight and log Pow value, together with the low water solubility indicate very low potential for dermal absorption. Similarly to mineral oils, deposition in the stratum corneum is expected to occur slowly; however, the substance is not sufficiently water soluble to partition from the stratum corneum into the epidermis

As dermal absorption cannot be greater than oral absorption, and the estimate of 2% oral absorption is already a worst-case estimate, no dermal absorption of the registered substance is expected to occur.

Justification for selection of acute toxicity – oral endpoint
This study was performed to a recognised OECD guideline, in a GLP certified laboratory and was reported in a good level of detail. It was assiged a reliability score of 1 in accordance with the criteria outlined in Klimisch (1997). It was therefore considered suitable to be the key study for this endpoint.

Justification for classification or non-classification

The results of the acute oral toxicity study are beyond the limits of classification and thus the test material does not require classification in line with Regulation (EC) 1272/2008.