Fatty acids, C16-18, tetraesters with 3,3'-oxybis[1,2-propanediol]

Endpoint summary

Description of key information

Skin irritation/corrosion (OECD 404): not irritating, GLP, 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

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

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

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study with acceptable restrictions. Lack of data on test substance.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

Lack of data on test substance.

GLP compliance:

yes

Species:

rabbit

Strain:

other: Kleinrusse, Chbb:HM

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Thomae, Biberach, Germany
- Age at study initiation: adult
- Weight at study initiation: 2.5 kg
- Housing: The animals were single housed in rabbit cages.
- Diet: Altromin 2023, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 7 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21
- Humidity (%): 45 - 55
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:

single application without washing

Observation period (in vivo):

3 d
Reading time points: 1, 6, 24, 48 and 72 h

Number of animals or in vitro replicates:

4 males

Details on study design:

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: fluorescein

Irritation parameter:

cornea opacity score

Basis:

other: mean out of all 4 animals

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritation parameter:

iris score

Basis:

other: mean out of all 4 animals

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility: not applicable

Irritation parameter:

conjunctivae score

Basis:

other: mean out of all 4 animals

Time point:

other: mean over 24, 48 and 72 h

Score:

0.08

Max. score:

3

Reversibility:

fully reversible within: 48 h

Irritation parameter:

chemosis score

Basis:

other: mean out of all 4 animals

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritant / corrosive response data:

The application of the test substance to one eye of each animal did not result in corneal opacity, iritis or swelling of the conjunctivae at any observation time point. Very slight redness of the conjunctivae was observed in 1/4 animals at the 24 h reading time point. The effect was reversible within 48 h after the application of the test substance.

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified

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 Fatty acids, C16-18, tetraesters with 3,3'-oxybis[1,2-propanediol] (CAS # 91050-80-5). 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
91050-80-5 (a) Target substance	RA: 63705-03-3	RA: 63705-03-3
63705-03-3 (b)	Not irritating	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.

 

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 Fatty acids, C16-18, tetraesters with 3,3'-oxybis[1,2-propanediol] (CAS # 91050-80-5).

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 Fatty acids, C16-18, tetraesters with 3,3'-oxybis[1,2-propanediol] (CAS 91050-80-5) are available, in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 a read-across from the structurally related analogue substance1,2,3-Propanetriol, homopolymer, diisooctadecanoate (CAS 63705-03-3) was conducted.

CAS 63705-03-3

The skin irritation of potential of 1,2,3-Propanetriol, homopolymer, diisooctadecanoate (CAS# 63705-03-3) was investigate according to OECD Guideline 404 (Kaestner, 1998). The dorsal area of the trunk of three male Kleinrussen rabbits was exposed to unchanged test material for 4 hours. Skin reactions were assessed using the Draize scheme approx. 1, 24, 48, 72 hours and 7 days after removal of the test substance. The dermal application of the test substance did not result in edema in any of the animals tested at any observation time point. Very slight to slight erythema formation was observed in 3/4 animals at the 24 and 48 h reading time points. At the 72 h reading time point, slight and moderate erythema formation was observed in 2/4 animals. The effects were reversible in all animals within 7 days after the application of the test substance.

 

A human patch test is available to evaluate the skin sensitising potential of 1,2,3-Propanetriol, homopolymer, diisooctadecanoate (CAS# 63705-03-3) was conducted according to Guidelines for the Assessment of Skin Tolerance of Potentially Irritant Cosmetic Ingredients (COLIPA, 1997) und under GCP conditions. 20 volunteers (females and males) with intact and healthy skin were included in the study (Krächter, 1997). Patches soaked with 70 µL of 20% test material were applied under occlusive conditions on the backs of the volunteers for 24 h. The reading time points were 6, 24, 48 and 72 h after removal of the test substance. Exposure to the test substance (20% AS) leads to slight erythema in 3/20 volunteers and slight scaling in 2/20 volunteers. The mean scores after 6, 24, 48 and 72 h were 0.15 for erythema and 0.25 for erythema, edema, scaling and fissure. The skin compatibility of the test substance in comparison to 1% Texapon N25 and 0.5% SDS was good. 

After 24 h exposure, the test substance (20% AS) was not irritating to human skin.

Under the experimental conditions described, it was concluded, that no evidence of skin irritation properties were seen after treatment with 1,2,3-Propanetriol, homopolymer, diisooctadecanoate (CAS# 63705-03-3).

 

Eye irritation

Since no studies investigating the eye irritation potential ofFatty acids, C16-18, tetraesters with 3,3'-oxybis[1,2-propanediol] (CAS # 91050-80-5)are available, in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 a read-across from the structurally related analogue 1,2,3-Propanetriol, homopolymer, diisooctadecanoate (CAS 63705-03-3) was conducted.

CAS 63705-03-3

An acute eye irritation study was performed with 1,2,3-Propanetriol, homopolymer, diisooctadecanoate (CAS# 63705-03-3) according to OECD Guideline 405 (Kaestner, 1988).

0.1 mL of test substance was instilled in the conjuctival sac of one eye of 3 Kleinrussen rabbits. The animals were observed over 3 days. Eye irritation was scored by mean of the Draize scoring system at the following reading time points: 1, 6, 24, 48 and 72 hours. The application of the test substance to one eye of each animal did not result in corneal opacity, iritis or swelling of the conjunctivae at any observation time point. Very slight redness of the conjunctivae was observed in 1/4 animals at the 24 h reading time point. The effect was reversible within 48 h after the application of the test substance.

Under the experimental conditions described, it was concluded, that no evidence of eye irritation properties were seen after treatment with 1,2,3-Propanetriol, homopolymer, diisooctadecanoate (CAS# 63705-03-3).

 

 

Conclusions

Based on the available data on skin irritation there is no indication for skin irritation/corrosion of 1,2,3-Propanetriol, homopolymer, diisooctadecanoate (CAS# 63705-03-3).

Results of an eye irritation studies conducted the structurally related analogue substance with 1, 2,3-Propanetriol, homopolymer, diisooctadecanoate (CAS# 63705-03-3) did not show signs of eye irritation properties. Thus,Fatty acids, C16-18, tetraesters with 3,3'-oxybis[1,2-propanediol] (CAS # 91050-80-5) is not considered to be irritating for skin and eye.

Justification for selection of skin irritation / corrosion endpoint:
Hazard assessment is conducted by means of read-across from a structural analogue. The available study is 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 a structural analogue. The available study is 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 t, he 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.