Reaction products of decanoic acid and lauric acid with glycerol and polyglycerol

Endpoint summary

Description of key information

Acute oral toxicity: LD50 (rat, male/female) > 2000 mg/kg bw (OECD TG 401; GLP, RL2)

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:

1996-02-28 to 1996-03-27

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

adopted February 24 th, 1987

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Version / remarks:

July 31st, 1992

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Crj: CD(SD)

Remarks:

BR strain (VAF plus)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 4-6 weeks
- Weight at study initiation: approx. 100 g
- Fasting period before study: over night
- Housing:Animals were housed in groups of up to 5, by sex, in grid-bottomed cages suspended over cardboard lined excreta trays
- Diet (e.g. ad libitum): ad libitum, pelleted diet (SQC Rat and Mouse Maintenance Diet No. 1 Expanded, Special Diet Services, Witham, Essex)
- Water (e.g. ad libitum): ad libitum, mains drinking water in polypropylene bottles
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-26°C
- Humidity (%): 34-60%
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 100 mg/mL

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: In a preliminary study in one female and one male rat a dose of 2000 mg/kg bw was applied. Since no deaths occurred during the preliminary study the test item was similarly administrered to 5 female and 5 male rats.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were performed 30 min, 1h, 2h and 4h after dosing. Examinations were conducted daily thereafter. Bodyweight was recorded at the day of dosing and at day 1, 2, 3, 4, 8 and 15.
- Necropsy of survivors performed: yes

Preliminary study:

One female and one male rats were administered with 2000 mg/kg bw of the test item.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

act. ingr.

Mortality:

not observed

Clinical signs:

other: not observed

Gross pathology:

no abnormalties observed at necropsy

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of the test item was > 2000 mg/kg bw.

Executive summary:

In an acute oral toxicity study according to OECD Guideline 401 (1987) and EU method B.1 (1992), groups of fasted, 4-6 weeks old, Sprague Dawley rats (5 female/5 male) were given a single oral dose ofpolyglycerin caprinatein water at a dose of 2000 mg/kg bw and observed for 14 days.

 

Oral LD50 Males < 2000 mg/kg bw

      Females < 2000 mg/kg bw

      Combined < 2000 mg/kg bw

      no mortality occurred at the applied dose /limit test 

Polyglycerin caprinateis of low toxicity based on the LD50 in both sexes (not classified according to GHS criteria).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

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

In an acute oral toxicity study according to OECD Guideline 401 (1987) and EU method B.1 (1992), groups of fasted, 4-6 weeks old, Sprague Dawley rats (5 female/5 male) were given a single oral dose of polyglycerin caprinate in water at a dose of 2000 mg/kg bw and observed for 14 days.

No mortality occurred at the applied dose. The oral LD50 was >2000 mg/kg bw in male and female rats. 

Acute inhalation toxicity

Results of laboratory animal studies show a low acute toxicity after oral exposure. Therefore the acute intrinsic toxic activity of polyglycerin caprylate/caprinate is considered to be low. The occurrence of a systemic toxicity relevant to humans after inhalation is unlikely and therefore the conduct of an acute inhalation toxicity study is unjustified.

Acute dermal toxicity

The testing of acute dermal toxicity of polyglycerin caprylate/caprinate is scientifically not justified. According to the COMMISSION REGULATION (EU) 2016/863 of 31 May 2016 amending Annexes VII and VIII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards skin corrosion/irritation, serious eye damage/eye irritation, skin sensitisation and acute toxicity, recent “scientific analysis of available data from in vivo acute toxicity studies have shown that substances that are not toxic via the oral route may be expected with high certainty to be also non-toxic via the dermal route. Therefore, testing those substances via the dermal route does not provide essential information for their safety assessment.” The oral LD50 was determined to be > 2000 mg/kg bw. Thus, no toxicity via the dermal route is to be expected.

There are no data gaps in acute toxicity. Even though there is no information on acute toxicity in humans, there is no reason to believe that the low acute toxicity observed in experimental animals would not be relevant for human health.

Justification for classification or non-classification

Based on the available data, polyglycerin caprylate/caprinate does not need to be classified for acute toxicity according to regulation (EC) 1272/2008. Thus, no labelling is required.