Hydrocarbon waxes (petroleum), oxidized, Me esters, calcium salts

Endpoint summary

Description of key information

ORAL
LD50 = > 15 mL/kg bw, male/female rat, Anonymous 1980
INHALATION
In accordance with Column 2 (adaptation statement) of Annex VIII of Regulation (EC) 1907/2006 (REACH), it is considered justified to omit the acute inhalation toxicity study required under information point 8.5.2 on the basis of exposure considerations. The nature of the registered substance means that it is not potentially inhalable.
DERMAL
In accordance with Section 1 of Annex XI of Regulation (EC) 1907/2006 (REACH), it is considered justified to omit the acute dermal toxicity study required under information point 8.5.3 of Annex VII on the basis of exposure considerations; no dermal absorption of the registered substance is expected to occur.

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:

not reported

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: A non-GLP study performed to sound scientific principles with a sufficient level of detail to assess the quality of the relevant results.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

Animals were not necropsied

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 200 - 300 g
- Fasting period before study: food was withheld for 12 to 24 hours prior to dose administration
- Housing: wire mesh cages with raised floors
- Diet: commercial rat food diet
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Animals were maintained in a conditioned animal room

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

The dosage to be applied was calculated based on the animal's weight. The test material was administered to the animals using a 16 gauge "ball point" needle and syringe.

Doses:

5, 10 and 15 mL/kg

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed immediately following dose administration, after 1 hour, 4 hours and daily thereafter
- Frequency of weighing: animals were weighed at study initiation and again at study termination
- Necropsy of survivors performed: no
- Examinations performed: animals were observed for gross toxicological effects

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 15 mL/kg bw

Based on:

test mat.

Mortality:

None of the animals died during the study.

Clinical signs:

other: No clinical signs were reported.

Gross pathology:

Not applicable.

Other findings:

None reported.

Table 1: Results

Sex	No. of animals	Initial weight (average in g)	Dosage (mL/kg)	14 day mortality ratio	Final weight (average in g)
F	5	211	5	0/5	248
M	5	240	5	0/5	303
F	5	224	10	0/5	270
M	5	219	10	0/5	323
F	5	237	15	0/5	259
M	5	259	15	0/5	313

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the study, the acute oral LD50 of the test material was determined to be in excess of 15 mL/kg. The study is considered to be reliable, relevant and adequate for risk assessment and classification and labelling purposes.

Executive summary:

The acute oral toxicity of the test material was determined following a method similar to that outlined in the standardised guideline OECD 401. During the study, 5 Sprague Dawley rats of each sex were administered test material, by gavage, at dosage levels of 5, 10 and 15 mL/kg bw. Following dosing, animals were observed for a period of 14 days for signs of gross toxicological effects.

Under the conditions of the study, none of the animals died, no gross effects were noted and all animals gained weight. The acute oral LD50 of the test material was subsequently determined to be in excess of 15 mL/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The available study contains no data with regard to GLP; it was conducted to a methodology which is analogous to that of standardised guideline OECD 401. Since the report contains a sufficient level of detail to assess the quality of the relevant results, the study was assigned a reliability score of 2 in accordance with the criteria of Klimisch (1997).

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

Oral

The acute oral toxicity of the test material was determined following a method similar to that outlined in the standardised guideline OECD 401. During the study, 5 Sprague Dawley rats of each sex were administered test material, by gavage, at dosage levels of 5, 10 and 15 mL/kg bw. Following dosing, animals were observed for a period of 14 days for signs of gross toxicological effects.

Under the conditions of the study, none of the animals died, no gross effects were noted and all animals gained weight. The acute oral LD50 of the test material was subsequently determined to be in excess of 15 mL/kg bw.

Inhalation

The nature of the registered substance means that it is not potentially inhalable; the substance has low vapour pressure and therefore is unlikely to be available for inhalation as a vapour. The low water solubility, high molecular weight and the log Pow value of >9.4 obtained for the structural analogue 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 lysososmes and peroxisomes.

Dermal

The physical state, high molecular weight and log Pow value of >9.4 obtained for the structural analogue, 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
Only one study is available.

Justification for classification or non-classification

In accordance with with criteria for classification as defined in Annex I, Regulation 1272/2008, the test material does not require classification as no signs of toxicity were noted during the course of the acute oral toxicity study.