Hydrocarbon waxes (petroleum), oxidized

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:

experimental study

Adequacy of study:

key study

Study period:

8th Feburary 1993 to 17th March 1993

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study performed in accordance with generally accepted scientific principles, with incomplete reporting on methodological deficiencies, which do not affect the quality of the relevant results.

Qualifier:

equivalent or similar to guideline

Guideline:

other: 40 CFR Part 798, EPA Health Effects Testing Guidelines - Subpart B - General Toxicity Testing, September 1985.

Deviations:

yes

Remarks:

: observations were taken according to a different time scale. Day 7 bodyweights were taken on day 9 and female observations on day 4 were not taken.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Buckshire Corp., Perkasie, PA 18944 (U.S.D.A. License # 23-BL).
- Animals were housed and maintained according to the Guide for the Care and Use of Laboratory Animals (NIH Publication No. 86-23).
- Weight at study initiation: 200 - 240 g, variation did not exceed ± 20% on the average weight for either sex.
- Fasting period before study: Overnight prior to dosing.
- Housing: Housed 5 per cage by sex, in stainless steel elevated wire cages.
- Diet (e.g. ad libitum): Wayne® Rodent BLOX® 8604 ad libitum.
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: At least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.4 - 23.0 ºC.
- Humidity (%): 36 - 54 %.
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle.

IN-LIFE DATES: From: 24th February 1993 To: 10th March 1993

Route of administration:

oral: feed

Vehicle:

other: 4 ml peanut butter and 2 ml of honey.

Details on oral exposure:

- The dosed feed was completely consumed within 24 hours by all animals.

Doses:

- 5000 mg/kg bw.

No. of animals per sex per dose:

- 5 male and 5 female.

Control animals:

not specified

Details on study design:

OBSERVATIONS
- Duration of observation period following administration: 14 days. Observations were performed frequently on the day of dosing, then at least once daily.
- Frequency of weighing: Recorded at study initiation, day 9 and at sacrifice.
- Necropsy of survivors performed: Yes, on all animals which were euthanized with carbon dioxide.
- Other examinations performed: Signs of toxicity.

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

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

exposure considerations

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

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.