Reaction products of petrolatum (petroleum), oxidized, esterified with methanol

Endpoint summary

Description of key information

Oral route: LD50 determined to be > 15 mL/kg bw (equivalent or similar to OECD 401).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: oral

Type of information:

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

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Justification for type of information:

See read-across justification attached in Section 13.

Reason / purpose for cross-reference:

read-across source

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 15 mL/kg bw

Based on:

test mat.

Reference 2

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:

study well documented, meets generally accepted scientific principles, acceptable for assessment

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:

No clinical signs were reported.

Body weight:

All animals gained weight during the study.

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

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 route: Acute oral toxicity of an analogue test material (EC 271-638-7) 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 analogue test material was subsequently determined to be in excess of 15 mL/kg bw.

Dermal route: Experimental data shows that the substance is a viscous liquid for which low acute oral toxicity has been demonstrated by an analogue substance and repeated exposure of the skin is not expected under normal conditions of use. In addition, the test material has been shown to be stable (decomposition from approximately 211 °C (484 K) at 98 KPa) and the determined vapour pressure is low (0.0732 Pa at 25 °C). These data indicate that the potential for dermal absorption after exposure to vapour is low. Furthermore, the substance is a UVCB with a relatively high molecular weight, is poorly soluble (1.45 x 10E-03 gTOC/L at 20.0 ± 0.5 °C based on a nominal loading rate of 0.1 g/L.) and has a Log10 Kow value of > 10.0. Consequently, and in accordance with ECHA Guidance on Information Requirements and Chemical Safety Assessment Chapter R.7c: Endpoint specific guidance (Version 2.0; November 2014), the substance is considered insufficiently soluble to partition from the stratum corneum into the epidermis and the majority of UVCB constituents are likely to be too large to favour dermal absorption (molecular weight > 100 g/moL and Log10 Pow > 4). Investigation of acute toxicity via the dermal route is therefore contraindicated.

Inhalation route:The substance is a viscous liquid that only decomposes from 211 °C (484 K) at 98 KPa and the vapour pressure has been determined to be 0.0732 Pa at 25 °C. It is therefore expected that inhalation exposure from identified uses will be low. In addition, the most likely route of exposure for workers and consumers is the dermal route.

Justification for classification or non-classification

In an investigation of acute toxicity involving an analogue substance (EC 271-638-7), none of the animals died, no clinical effects were reported, all animals gained weight and no gross effects were found at necropsy. Classification under the terms of Regulation (EC) No 1272/2008 is therefore not required.