Oleic acid, monoester with oxybis(propanediol)

Endpoint summary

Description of key information

Skin irritation/corrosion (OECD 404): not irritating, analogue approach
Eye irritation/corrosion (OECD 405) not irritating, GLP, analogue approach

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Justification for grouping of substances and read-across

There are no data available on the skin and eye irritating potential of Oleic acid, monoester with oxybis(propanediol) (CAS# 49553-76-6)). In order to fulfil the standard information requirements set out in Annex VIII, 8.1 and 8.2, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from structurally related substances was conducted.

In accordance with Article 13 (1) of Regulation (EC) No 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met.” In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across).

Having regard to the general rules for grouping of substances and read-across approach laid down in Annex XI, Item 1.5, of Regulation (EC) No 1907/2006, whereby substances may be predicted as similar provided that their physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity, the substance listed below are selected as reference substances for hazard assessment.

Overview of skin/ eye irritation

CAS	Skin Irritation/Corrosion	Eye Irritation/Corrosion
49553-76-6 (a) Target substance	RA: 90431-25-7 RA: 31566-31-1 RA: 91744-13-7	RA: 67965-56-7
90431-25-7 (b)	Not irritating	Not irritating
31566-31-1	Not irritating	--
91744-13-7	Not irritating	Not irritating
67965-56-7	--	Not irritating

(a) Substances subject to the REACh  Phase-in registration deadline of 31 May 2013 are indicated in bold font. Only for this substance a full set of experimental results and/or read-across is given.

 (b) Substances that are either already registered under REACh or not subject to the REACh  Phase-in registration deadline of 31 May 2013 are indicated in normal font. Lack of data for a given endpoint is indicated by “--“.

 

The above mentioned substances are considered to be similar on the basis of structural similarity resulting in similar properties and/or activities. The available endpoint information is used to predict the same endpoints for Oleic acid, monoester with oxybis(propanediol) (CAS# 49553-76-6).

A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).

 

Skin Irritation

Since no studies investigating the skin irritation of Oleic acid, monoester with oxybis(propanediol) (CAS# 49553-76-6) are available, in accordance with Regulation (EC) No. 1907/2006 Annex XI, 1.5 a read-across from structurally related analogue substances isooctadecanoic acid, mono-, di- and triesters with triglycerol (CAS# 90431-25-7), stearic acid, monoester with glycerol (CAS# 31566-31-1), and glycerides, C14-18 and C16-22-unsatd. mono- and di- (CAS# 91744-13-7) was conducted.

 

CAS 90431-25-7 

The skin irritation of potential of isooctadecanoic acid, mono-, di- and triesters with triglycerol was investigate according to OECD Guideline 404 (Dufour, 1997). Three New Zealand White rabbits were exposed to unchanged test material for 4 hours. The rabbits were observed for 3 days. Skin reactions were assessed using the Draize scheme approx. 1, 24, 48, 72 hours after removal of the test substance. The exposure period of four hours resulted in slight (grade 1) erythema on the skin of all three animals tested starting 1 hour following application and was fully reversible within 72 hours following application.  No edema and no further skin reactions were noted in any animal. The mean erythema score out of three animals over 24, 48 and 72 hours was 0.7.

Thus, under the test conditions the test substance was considered to be not irritating to the skin.

 

 

CAS 31566-31-1 

Stearic acid, monoester with glycerol (CAS# 31566-31-1) was investigated in a primary skin irritation study according to OECD 404 (Dufour, 1993). The treated skin of three New Zealand White rabbits was exposed to 0.5 mL unchanged test material for 4 hours under semi-occlusive conditions. After exposure the skin was cleaned from the residual test substance. The rabbits were observed for 3 days. Skin reactions were assessed using the Draize scheme approx. 1, 24, 48, 72 hours after removal of the test substance. The exposure period of four hours resulted in slight erythema in one animal 1 h after application. No edema and no further skin reactions were noted in any animal 24-72 hours post application. Thus, under the test conditions the test substance was considered to be not irritating to the skin.

 

 

CAS 91744-13-7

For glycerides, C14-18 and C16-22-unsatd. mono- and di- (CAS# 91744-13-7), a primary skin irritation study according to OECD Guideline 404 (Steiling, 1990) and GLP condition was performed. The shaved dorsal skin of three Kleinrussen rabbits was exposed to 0.5 mL unchanged test material for 4 hours under semi-occlusive conditions. The rabbits were observed for 7 days. Skin reactions were assessed using the Draize scheme approx. 1, 24, 48, 72 hours 7 days after removal of the test substance. After 1h 2/3 animals showed slight erythema being reversible within 24h and 7 days, respectively. After 48 h 1/3 animals showed slight erythema being reversible after 72 h. Edema formation was apparent in 1/3 animals at the 48 and 72 h reading time point and was reversible within 7 days. The mean erythema scores over 24, 48 and 72 hours were 0.3, 0, and 1.3 for animal #1, #2 and #3 respectively.

The mean edema scores over 24, 48 and 72 hours were 0 for animal #1 and #2 and 0.7 for animal #3. Thus, under the test conditions the test substance was considered to be not irritating to skin.

 

Eye irritation

Since no studies investigating the eye irritation potential of Oleic acid, monoester with oxybis(propanediol) (CAS# 49553-76-6) are available, in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 a read-across from the structurally related analogue substance 9-Octadecenoic acid (Z), diester with oxybis[propanediol] (CAS# 67965-56-4) was conducted.

 

CAS 67965-56-4

1 animal study investigating the eye irritation potential of 9-Octadecanoic acid (Z), diester with oxybis[propanediol] (CAS# 67965 -56 -4) is available. An acute eye irritation study was conducted with the test substance according to OECD Guideline 405 (Scheel, 2011). The undiluted test substance was instilled into the conjunctival sac of one eye of three rabbits for 24 hours. The second eye served and negative control. The animals were observed for 72 hours. No effects were observed in all animals tested.

Therefore the test substance was considered not irritanting to eye.

 

Furthermore, the HET-CAM was conducted to measure irritation potential of 9-Octadecanoic acid (Z), diester with oxybis[propanediol] (CAS# 67965 -56 -4) following the protocol published in the 1990s by the cosmetic industry (Brantom et al., 1997; Steiling et al., 1999; Sterzel et al., 1990) (Scheel, 2011).and under GLP conditions. 300 µL or a sufficient amount to cover at least 25% of the CAM of the undilutedtest substance were applied onto 2 (pretest) and 6 chicken eggs (main test). Occurrence of specific (individual time of occurence of effect) effects on the CAM and/or its blood vessels like hemorrhage (H), Lysis (L), intravasal and/or extravasal coagulation (C) RT scores - was recorded - during a maximum observation period of 300 seconds. A test item specific irritation score was determined by equal valuation of individual effects without using ranking factors. The benchmark chemical was tested in parallel and both irritation scores (mean over all eggs) were used to calculate the Q-value (quotient of both scores).  

The Q-score calculated as the mean of 6 eggs resulted to be lower than 1.2. Therefore the test item was predicted to be not irritating to eye.

 

Conclusions

Based on the available data there is no indication for skin irritation/corrosion of isooctadecanoic acid, mono-, di- and triesters with triglycerol (CAS# 90431-25-7), stearic acid, monoester with glycerol (CAS# 31566-31-1), and glycerides, C14-18 and C16-22-unsatd. mono- and di- (CAS# 91744-13-7).

Results of an eye irritation studies (in vivo and in vitro) with the structurally related source substance 9-Octadecanoic acid (Z), diester with oxybis[propanediol] (CAS# 67965 -56 -4) did not show signs of eye irritation.

 

A detailed reference list is provided in the technical dossier (see IUCLID, section 13) and within CSR.

Justification for selection of skin irritation / corrosion endpoint:
Hazard assessment is conducted by means of read-across from structural analogues. All available studies are adequate and reliable based on the identified similarities in structure and intrinsic properties between source and target substances and overall quality assessment (refer to the endpoint discussion for further details).

Justification for selection of eye irritation endpoint:
Hazard assessment is conducted by means of read-across from structural analogues. All available studies are adequate and reliable based on the identified similarities in structure and intrinsic properties between source and target substances and overall quality assessment (refer to the endpoint discussion for further details).

Justification for classification or non-classification

Based on read-across from structurally similar substances, the available data on skin and eye irritation do not meet the classification criteria according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.