Fatty acids, C16-18 (even numbered), esters with 1,2,3-propanetriol and oligomers, ethoxylated

Endpoint summary

Description of key information

To assess the dermal irritation potential of the test substance registered one OECD 404 study in rabbits is available.

To assess the eye irritation potential of the test substance registered one OECD 405 study in rabbits is available.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1984-05-08 to 1984-05-15

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

OECD Guideline 1981

Deviations:

not applicable

GLP compliance:

yes

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL: Hostacerin DGS
- lot/batch No.of test material: E06-400 282 (Date of production 1983-10-25),
- Physical state /colour: white flakes
- Purity test date: about 100 % Diglycerindistearat-Oxethylat, small amount of free stearic acid and polyglycerin

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: in the dark at 22 °C
- Stability under test conditions: n.a.
- Solubility of the test substance in the solvent/vehicle: soluble in warmed-up fat

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Final preparation of a solid: soluble in warmed-up fat

Species:

rabbit

Strain:

New Zealand White

Remarks:

Hoe : HIMK (SPFWiga)

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventional breeding
- Age at study initiation: n.a.
- Weight at study initiation: 2.6 to 4.1 kg
- Housing: single cages
- Diet (e.g. ad libitum): Altromin 2123 diet - Rabbit, Altromin GmbH, Lage /Lippe
- Water (e.g. ad libitum): deionized, chlorianted water, automated watering place
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2 °C
- Humidity (%): 55 ± 10%
- Air changes (per hr): n.a.
- Photoperiod (hrs dark / hrs light): 12 hrs

IN-LIFE DATES: From: 1984-05-08 To: 1984-05-15

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

Amount applied: 0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

7 days after removal of plaster.

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm2
- % coverage:
- Type of wrap if used: semiocclusive wrap

REMOVAL OF TEST SUBSTANCE
- Washing (if done): n.a.
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
(indicate if minutes, hours or days): 30 - 60 minutes, 24, 48, 72 hours and 7 days after removal of plaster.

SCORING SYSTEM:
- Method of calculation: numerical accrding to Draize.

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24 h

Score:

2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24 h

Score:

2

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24 h

Score:

1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

48 h

Score:

1

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

48 h

Score:

1

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

48 h

Score:

1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

72 h

Score:

1

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

72 h

Score:

1

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

72 h

Score:

1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

1.22

Max. score:

2

Reversibility:

fully reversible within: 7 days

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of the OECD 404 study, test substance is not irritating to the skin and thus not subject to labeling requirements.

Executive summary:

The test substance was tested for primary skin irritation according to OECD test guideline 404 using three New Zealand albino rabbits. Only animals with intact skin were used. Each animal was treated with 0.5 mL undiluted test substance warmed-up to 40°C. The test item was applied over the whole surface of a 2.5 x 2.5 cm cellulose patch on piece of surgical plaster. The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage. The exposure period was 4 hours. After the exposure all remnants of the test material were carefully removed from the skin. Examinations of skin took place after 30-60 minutes, 24, 48 and 72 hours after removal of the patches. Erythema and edema were evaluated numerically according to the score of Draize.

24 hours after removal of the patches two animals exhibited a well defined erythema (score 2), whereas the third animal showed slightly visible erythema (score 1). At 48 and 72 hours after removal of the patches all animals exhibited a slightly visible erythema (score 1). There were no edema observed at any time point at any animal (score 0). At 7 days after removal of patch all animals were free of skin reactions. A mean score of 1.2 for erythema and edema is determined.

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:

experimental study

Adequacy of study:

key study

Study period:

1984-05-08 to 1984-05-11

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL: Hostacerin DGS
- lot/batch No.of test material: E06-400 282 (Date of production 1983-10-25),
- Physical state /colour: white flakes
- Purity test date: about 100 % Diglycerindistearat-Oxethylat, small amount of free stearic acid and polyglycerin

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: in the dark at 22 °C
- Stability under test conditions: n.a.
- Solubility of the test substance in the solvent/vehicle: soluble in warmed-up fat

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Final preparation of a solid: soluble in warmed-up fat

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventional breeding
- Age at study initiation: n.a.
- Weight at study initiation: 3.0 to 3.2 kg
- Housing: single cages
- Diet (e.g. ad libitum): Altromin 2123 diet - Rabbit, Altromin GmbH, Lage /Lippe
- Water (e.g. ad libitum): deionized, chlorianted water, automated watering place
- Acclimation period: n.a.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2 °C
- Humidity (%): 55 ± 10%
- Air changes (per hr): n.a.
- Photoperiod (hrs dark / hrs light): 12 hrs

Controls:

yes, concurrent no treatment

other: The other eye of each animal serves as untreated control

Amount / concentration applied:

0.1 mL of test item warmed up to about 40°C

Duration of treatment / exposure:

24 hours (24 hours after application the eyes were washed with physiological saline warmed up to 37°C)

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: Treated eyes were washed with physiological saline warmed up to 37°C.
- Time after start of exposure: 24 hours after application

SCORING SYSTEM: DRAIZE

TOOL USED TO ASSESS SCORE: Fluorescein- Natrium-Solution (0.01 %); hand-slit lamp, examination of eys under UV-light.

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritant / corrosive response data:

One hour post application of test substance, diffuse to carmesin-red reddening and injected blood vessels were observed at the conjunctivae (one animal score 2, and two animals score 1). 24 hours post application all animals were free of any irritating signs.

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of this OECD 405 study, the test substance is not irritating to the eye.

Executive summary:

The test material was tested for primary eye irritation in three New Zealand albino rabbits according to OECD test guideline 405. 0.1 mL of undiluted test substance warmed up to about 40°C was applied once to the conjunctival sac of the left eyes of three rabbits. The untreated eye served as a respective control. The exposure period was 24 hours. 24 hours after instillation and at all the designated examination times at which corneal examination with fluorescein sodium took place, the treated eyes were washed out thoroughly with isotonic saline at approx. 37°C. The eyes were also examined for corneal lesions under UV light after instillation of one drop of 0.01 % fluorescein-sodium solution. One hour after treatment the conjunctivae of all animals showed some definitely injected blood vessels as well as a carmesin-red reddening. 24 hours after application all signs of irritation were reversible. The mean irrtation score was determined to be zero.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Justification for classification or non-classification

Based on all the available test results for skin irritation and in accordance with the criteria for classification as defined in Annex I, Regulation 1272/2008,it is concluded, that the test substance registered does not require classification for skin irritation.

Based on all the available test results for eye irritation and in accordance with the criteria for classification as defined in Annex I, Regulation 1272/2008,it is concluded, that the test substance registered does not require classification for eye irritation.