Isooctadecanoic acid, monoester with propane-1,2-diol

Endpoint summary

Description of key information

Oral (OECD 401) rat, m/f: LD50 > 2000 mg/kg bw

Dermal (read across, OECD 402) rat, m/f: LD50 > 2000 mg/kg bw

The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the glycol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly.

For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the glycol esters category.

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:

29 Jun - 3 Aug 1989

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

adopted in 1987

Deviations:

yes

Remarks:

purity not specified

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Remarks:

SPF

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: IFFA Credo (L'Arbresle, France)
- Age at study initiation: 2 months
- Weight at study initiation: 190.2 +/- 3.2 g (males), 167.6 +/- 5.6 g (females)
- Fasting period before study: yes, for 16 h prior treatment
- Housing: 5 per box in makrolon boxes (46.5 x 31 x 19 cm) with soft wood sawdust.
- Diet: ad libitum, rat feed
- Water: tap water ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.5 +/- 2.5
- Humidity (%): 52 +/- 8
- Air changes (per hr): 14
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 29 Jun to 13 Jul 1989

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The product was administered undiluted.

Doses:

2000 mg/kg bw (2.15 mL/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 mortality check: twice daily
- Frequency of weighing: D0 just prior treatment, D4, D7 and D14
- Necropsy of survivors performed: yes
- Clinical examinations: During the 3 hours following product administration, the animals were quasi continuously observed in order to note the clinical signs of toxicity.
During the following 14 days, a daily observation was made. Motor coordination, convulsions, motility, stereotypies, reflexes, breathing, piloerection, temperature, sweating, salivation, tremor, pupil size, eyelid opening, lacrimation, skin color, defecation, urine were recorded.

Key result

Sex:

male/female

Dose descriptor:

LD50

Remarks:

rat

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No mortality occurred during this study.

Clinical signs:

other: No abnormal clinical signs were seen. No changes in behavior were seen.

Body weight:

other body weight observations

Remarks:

All animals gained weight throughout the study.

Gross pathology:

No macroscopic lesions.

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

>= 2 000 mg/kg bw

Quality of whole database:

The available information comprises an adequate and reliable study (Klimisch score 2). The selected study is sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006.

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

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

Remarks:

Summary of available data used for the endpoint assessment of the target substance

Adequacy of study:

key study

Justification for type of information:

Refer to analogue justification provided in IUCLID section 13.

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

no indication of skin irritation up to the relevant limit dose level

Remarks:

Source: CAS 37321-62-3

Additional acute dermal toxicity data from an in vivo study with the source substance CAS 1323 -39 -3/29013 -28 -3 as 2.5% preparation in makeup foundation product in rabbits, corresponding to 50 mg/kg bw test substance was found to be non toxic.

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.

Conclusions:

The read across approach is justified in the analogue justification. The target and source substances are considered unlikely to differ in their acute toxicity potential. The acute dermal LD50 was found to be > 2000 mg/kg bw for the analogue source substance, Dodecanoic acid, ester with 1,2-propanediol (CAS 37321-62-3) and no indication of acute dermal toxicity was found for a preparation with 2.5% stearic acid, monoester with propane-1,2-diol / 2-hydroxypropyl stearate/Palmitic acid, monoester with 1,2-propanediol (CAS 1323-39-3/29013-28-3). Therefore, no acute dermal toxicity potential is expected for target substance isooctadecanoic acid, monoester with propane-1,2-diol (CAS 68171-38-0).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

>= 2 000 mg/kg bw

Quality of whole database:

The available information comprises adequate and reliable (Klimisch score 1) and secondary source data (Klimisch score 4) from source substances. The selected studies are sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006.

Additional information

The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the glycol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly.

For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the glycol esters category.

Acute oral toxicity

CAS 68171-38-0

The acute oral toxicity of Isooctadecanoic acid, monoester with propane-1,2-diol (CAS 68171-38-0) was assessed in a GLP conducted according to OECD guideline 401 (key, 1989). Administration of 2000 mg/kg bw to 5 rats per sex via oral gavage did not cause mortality and no clinical signs were recorded during the 14-day observation period. There were no effects on body weight. The acute oral LD50 value in male and female Sprague-Dawley rats was found to be > 2000 mg/kg bw.

 

Acute dermal toxicity

CAS 37321-62-3

An acute dermal toxicity GLP study (limit test) was performed with 1, 2-Propandiol-mono/di-dodecanoat (CAS 37321-26-3) according to OECD guideline 402 (key, 1992). 2000 mg/kg bw of the test substance was applied to the skin of 5 Wistar rats/sex under an semi-occlusive dressing for 24 hours. No mortality occurred and no abnormal clinical signs were observed. No abnormal skin appearance was observed. Body weights were within the expected range for this species and strain. The LD50 value in male and female rats was > 2000 mg/kg bw.

 

CAS 1323-39-3/29013-28-3

As reported in secondary literature the dermal effects of Propylene Glycol Stearate/ Propylene Glycol Palmitate (CAS 1323-39-3/29013-28-3) were investigated in an acute dermal toxicity study performed in rabbits in 1980 (supporting, 1983). 2000 mg/kg bw of the product containing 2.5% of test substance, equivalent to 50 mg/kg bw of test substance was applied to the clipped intact and abraded skin of a total of 10 rabbits for 24 hours under occlusive conditions. The product was found to be non-toxic under the conditions of the test.

 

Overall conclusion for acute toxicity

The reliable data available for the target and source substances indicate a very low level of acute toxicity following the oral and dermal route, as LD50 values were greater than the administered limit values. Therefore, as the available data did not identify any acute toxicity, Isooctadecanoic acid, monoester with propane-1,2-diol (CAS 68171-38-0) is not considered to be hazardous following acute exposure via the oral and dermal route.

Justification for classification or non-classification

According to Article 13 of Regulation (EC) No. 1907/2006 "General Requirements for Generation of Information on Intrinsic Properties of substances", information on intrinsic properties of substances may be generated by means other than tests e.g. from information from structurally related substances (grouping or read-across), provided that conditions set out in Annex XI are met. Annex XI, "General rules for adaptation of this standard testing regime set out in Annexes VII to X” states that “substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances. This avoids the need to test every substance for every endpoint". Since the analogue concept is applied to Isooctadecanoic acid, monoester with propane-1,2-diol (CAS 68171-38-0), data will be generated from data for reference source substance(s) to avoid unnecessary animal testing. Additionally, once the analogue read-across concept is applied, substances will be classified and labelled on this basis.

Therefore, based on the analogue read-across approach, the available data on acute toxicity do not meet the classification criteria according to Regulation (EC) 1272/2008 and are therefore conclusive but not sufficient for classification.