Oleic acid, monoester with oxybis(propanediol)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

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

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well documented publication which meets basic scientific principles.

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

2011

Materials and methods

Principles of method if other than guideline:

The HET-CAM was used to measure irritation potential of chemicals following the protocol published in the 1990s by the cosmetic industry (Brantom et al., 1997, Toxicology In Vitro, 11, 141-179; Steiling et al., 1999, Toxicology In Vitro, 13, 375-384; Sterzel et al., 1990, Toxicology In Vitro, 4, 698-701) and was evaluated in a number of studies including the European COLIPA validation study (Brantom et al., 1997, Toxicology In Vitro, 11, 141-179). The results were obtained either using the Reaction Time Method (RT) (Steiling et al., 1999, Toxicology In vitro, 13, 375-384).

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

67965-56-4

EC Number:

614-187-7

Cas Number:

67965-56-4

IUPAC Name:

67965-56-4

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): 9-Octadecanoic acid (Z)-diester with oxybis[propanediol]
- Physical state: liquid
- Analytical purity: 100 %

Test animals / tissue source

Species:

other: in vitro

Strain:

other: chicken eggs

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: internal standard (5% aqueous solution of sodium magnesium lauryl-myristyl-6-ethoxysulfate) with well-known irritating potential was used as benchmark for categorization of irritation potential

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 300 µL or sufficient amount to cover at least 25% of the CAM
- Concentration (if solution): 100%

Duration of treatment / exposure:

300 seconds

Observation period (in vivo):

300 seconds

Number of animals or in vitro replicates:

2 eggs in pretest and 6 eggs in main test

Details on study design:

SCORING SYSTEM:
Effects: occurrence of specific effects on the CAM and/or its blood vessels, H - Hemorrhage, L - Lysis, C - intravasal and/or extravasal coaggulation
RT scores - individual time of occurrence of effects were 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). This Q-value is the relevant parameter for prediction of irritancy classes (see table 1 under "Any other information on material and methods including tables").

Results and discussion

In vivo

Results

Irritation parameter:

other: Q-score

Basis:

mean

Remarks:

egg#1 - egg#6

Time point:

other: up to 300 seconds

Score:

< 1.2

Irritant / corrosive response data:

no details given

Other effects:

no other effects stated

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

DSD: not classified
CLP: not classified