Registration Dossier

Diss Factsheets

Administrative data

Description of key information

A study to determine acute dermal toxicity was deemed not to be scientifically necessary for PPG-2 myristyl ether propionate. This is based on existing information presented in an acute oral test and an in vivo dermal irritation test that indicate a lack of toxicity. Following a 14-day in vivo toxicity study in Wistar-derived albino rats, it was found that oral administration of PPG-2 myristyl ether propionate at 5 g/kg did not result in any mortality or symptoms of toxicity. Subsequently, an LD50 of >5 g/kg was assigned to the substance and classification was demonstrated not to be necessary (CLP Regulation (EC) No. 1272/2008).

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:
July 14, 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: Acute Toxicity
Version / remarks:
Method by Hagen, E. C. (1959) in Appraisal of the Safety of Chemicals in Food, Drugs, and Cosmetics. Division of Pharmacology, Food and Drug Administration, Department of Health, Education, and Welfare, 17 - 25
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
other: Wistar-derived albino rats
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Summit View Farm, Belvidere, New Jersey (conditioned prior to use)
- Weight at study initiation: 186 - 242 g
- Fasting period before study: Fasted overnight prior to test material administration
- Diet: Ad libitum with Wayne animal feed
- Water: Ad libitum
- Acclimation period: Maintained under standard laboratory conditions for a minimum of seven days prior to test material administration
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
Single dose of 5 g/kg bw
No. of animals per sex per dose:
Five male and five female rats were dosed individually
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations for signs of pharmacologic activity and drug toxicity at 1, 3, 6, and 24 hours post-dosage and thereafter on each day
- Necropsy of survivors performed: Complete gross necropsy performed at the conclusion of day 14
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 other: g/kg bw
Based on:
test mat.
Mortality:
No mortality observed
Body weight:
Body weight had increased in all rats by day 14 relative to day 0
Interpretation of results:
GHS criteria not met
Conclusions:
Following an in vivo 14-day toxicity study in rats via the oral route, PPG-2 myristyl ether propionate was found not to have induced any symptoms of toxicity and was subsequently assigned an LD50 of >5 g/kg bw. Classification in line with CLP Regulation (EC) No. 1272/2008 is not required.
Executive summary:

An in vivo acute toxicity study via the oral route was undertaken in mixed sex Wistar-derived albino rats over a 14-day period according to the procedure recommended by Hagan (1959) in the Appraisal of the Safety of Chemicals in Foods, Drugs, and Cosmetics. Following an overnight fasting period, a single dose of 5 g/kg PPG-2 myristyl ether propionate was administered by gavage according to bodyweight. Food and water were available ad libitum. All rats were observed for pharmacologic activity and toxicity at 1, 3, 6, and 24 hours post-dosage and thereafter on day 2, 3, 4, 5, 6, 7, and 14. Animals were then sacrificed and subjected to complete gross necropsy at the termination of the experiment. Over the study, no rats perished and no symptoms of toxicity were observed. Consequently, PPG-2 myristyl ether propionate was concluded not to be a toxic substance under the conditions of the test with an assigned LD50 of >5 g/kg bw. Hazard classification was not required (CLP Regulation (EC) No. 1272/2008).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
other justification
Justification for data waiving:
other:
Justification for type of information:
A study was performed to determine the vapour pressure of PPG-2 myristyl ether propionate. Using the isoteniscope technique, a final value of < 100 Pa at 20 °C was calculated as the mean of three replicates. Taking account of the low vapour pressure of the substance, testing for acute toxicity by the inhalation route is not deemed appropriate in accordance with REACH Annex VIII, 8.5.2.
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

The endpoint value for acute oral toxicity was attained from a key study that was undertaken according to a protocol described by Hagan (1959) that was published by the United States Division of Pharmacology, Food and Drug Administration (Department of Health, Education, and Welfare). The experiment occurred prior to the U.S. Good Laboratory Practise (GLP) regulations (21 CRF Part 58) that became effective in June 1979. The final conclusion has been assigned a Klimisch score of 2 (reliable with restrictions) given that the study is based on a standard guideline and its restrictions have been concluded to be acceptable.

Justification for classification or non-classification