C18 (branched) fatty acids, esters with mono-, di-, and tri-glycerol

Endpoint summary

Description of key information

To assess the dermal irritation potential of the test substance registered one OECD 404 study in rabbits and two

valid studies with a different study design in rabbits are available. Additionally one study with human volunteers is available.
To assess the eye irritation potential of the test substance registered two studies in rabbits are available (one OECD 405 and one study according to Federal Hazardous Substances Act, 16 CFR, Section 1500.42). Additional a study with a different study design is available as supportive study.

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:

1987-04-10

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well documented OECD 404 study.

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

not specified

Species:

rabbit

Strain:

New Zealand White

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

24, 48 and 72 hours after removal of patch

Number of animals:

3

Details on study design:

Hostacerin DGI 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 Hostacerin DGI. 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 with warm tap water. 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.

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48/72 h

Score:

0.1

Max. score:

2

Reversibility:

fully reversible

Remarks:

48 hours

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.22

Max. score:

2

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: no effects seen

Irritant / corrosive response data:

24 hours after removal of the patches one animal exhibited a well defined erythema, whereas the other two animals showed no signs of irritation at all. From 48 hours after removal of the patches all animals were free of skin reactions.

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the results of this study, technical grade of test item is not irritationg 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. 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 with warm tap water. 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 one animal exhibited a well defined erythema, whereas the other two animals showed no signs of irritation at all. From 48 hours after removal of the patches all animals were free of skin reactions.

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:

1987-04-07 to 1987-04-10

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well documented OECD 405 study.

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

not specified

Species:

rabbit

Strain:

New Zealand White

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

24 h

Observation period (in vivo):

up to 72 hours

Number of animals or in vitro replicates:

3

Details on study design:

The test material was tested for primary eye irritation in three New Zealand albino rabbits according to OECD test guideline 405. The animals had no ocular abnormalities. 0.1 mL of undiluted test substance 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.

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.11

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: no signs of irritation appeared

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: no signs of irritation appeared

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: no signs of irritation appeared

Irritant / corrosive response data:

One hour after treatment the conjunctivae on one animal showed some definitely injected blood vessels as well as a swelling with partial eversion of lids. The other two animals showed blood vessels definitly injected. 24 hours after application some definitely hyperaemic blood vessels were still present in one animal. From 48 hours p.a. all signs of irritation were reversible.

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the results from this OECD 405 study technical grade of test substance is not irritating to eyes and thus not subject to labeling requirements.

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 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 one animal showed some definitely injected blood vessels as well as a swelling with partial eversion of lids. The other two animals showed blood vessels definitely injected. 24 hours after application some definitely hyperaemic blood vessels were still present in one animal. From 48 hours p.a. all signs of irritation were reversible.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Skin irritation:

Data from an OECD 404 study in rabbits demonstrated that the test substance registered has no skin irritating potential under the test conditions. Two studies in rabbits performed with a prolonged exposure time of 24 hours can be regarded as a worst case condition. It could be demonstrated, that dermal application of 0.5 mL test substance to the rabbit’s skin for 24 hours did not lead to signs of irritation after application. Only the result of the study performed in 1980 has to be regarded as equivocal, but this result was not sufficient to warrant classification as a skin irritant. Although, the available human test data for skin irritation after a patch test are not required, the results support the overall result, that the test substance is not irritating to the skin.

Eye irritation:

In order to evaluate the eye irritation potential of the test substance registered two studies in rabbits are available. One study is performed according to guideline OECD 405 and one study according to Federal Hazardous Substances Act, 16 CFR, Section 1500.42. For the studies 0.1 mL of the test material was applied into one of each eye of three or six rabbits, i.e. in the key study or in the supporting study, respectively. In the key study the treated eyes were washed out 24 hours after application of the test item. The rabbits were observed for up to 72 hours to determine the grade of ocular reaction to the test material. All tested animals had a slight to mild positive reaction with the test material one hour after start of treatment which was fully reversible within 48hours.

In the supporting study the test material was found to produce mild positive reactions, such as erythema and swelling above normal, in four of six rabbits up to 48 hours. At the 72 hour observation time point all reactions were reversible.

An additional study performed in 1980 is used as supportive data. The test material registered was tested in different concentrations (i.e. undiluted, 10% and 0.1 % in physiol. Saline) in two rabbits per concentration. The assessment of the irritation potential was performed at 1, 7, 24, 48 and 72 hours and described. After application of the undiluted test substance mild to distinct reactions were found. Slight to distinct reddening and discharge were found after application of the 10% and the 1% solution. As the reversibility was not assessed under this study conditions the substance has slight irritation potential after the 72 hour observation. The result is assessed to be equivocal as no score numbering is given for findings and no recovery was performed.

However, the results on eye irritation studies are not sufficient to warrant classification.

Justification for selection of skin irritation / corrosion endpoint:
The study is performed in accordance to OECD 404 and is well documented.

Justification for selection of eye irritation endpoint:
The study is performed in accordance to OECD 405 and is well documented.

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.