Reaction products resulting from the esterification of C18 unsaturated fatty acid with glycerol and glycerol oligomers

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 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:

1984-10-23 to 1984-10-26

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Complete guideline conform study report available. Study is performed under GLP.

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Specific details on test material used for the study:

- Chemical name: Diglycerinsesquioleat
- Purity: about 100 %
- Lot No. FMFP355
- Appearance: yellow liquid
- Storage: In the dark at about 22°C
- Solubility: not soluble in water, soluble in most organic solvents

Species:

rabbit

Strain:

New Zealand White

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

None

Table 1.             Skin irritation/ corrosion test: Scoring results (acc. to Draize)

Time after treatment	30 – 60 min.			24 hrs			48 hrs			72 hrs
Animal no.	1	2	3	1	2	3	1	2	3	1	2	3
Erythema	0	0	0	0	0	0	0	0	0	0	0	0
Edema	0	0	0	0	0	0	0	0	0	0	0	0

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this test and the results obtained, it is concluded, that the test substance is not irritant to the skin.

Executive summary:

In order to evaluate the dermal irritant/corrosive potential of the test substance an in vivo test in rabbits was performed in 1984 which was in accordance to guideline OECD 404. 24 hours prior to treatment the animals back was shaved to receive a skin area of about 10 x10 square centimeters for treatment. Only animals with intact skin were chosen for the test. The 3 animals were each treated with 0.5 mL test substance per animal on the right flank, whereas the left side serves as control. The treated area was covered by an semi-occlusive bandage and fixed with a non-irritant tape for 4 hours. After these 4 hours, the bandage was removed and the skin washed with lukewarm water to remove remaining test substance. Mortality and clinical signs of toxicity were observed once daily. The skin was assessed for edema, eschar formation or erythema according to Draize, 60 minutes, 24, 48 and 72 hours after removing of bandage. No mortality occurred. No clinical signs of toxicity were observed. The overall mean scoring value is 0 for erythema and edema formation.

Under the conditions of this test and the results obtained, it is concluded, that the test substance is not irritant to the skin.

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:

1984-10-23 to 1984-10-26

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Complete guideline conform study report available. Study is performed under GLP.

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Specific details on test material used for the study:

- Chemical name: Diglycerinsesquioleat
- Purity: about 100 %
- Lot No. FMFP355
- Appearance: yellow liquid
- Storage: In the dark at about 22°C
- Solubility: not soluble in water, soluble in most organic solvents

Species:

rabbit

Strain:

New Zealand White

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

1 hour

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3

Details on study design:

In order to assess the eye irrtating potential of the test substance, 0.1 g of the undiluted test item was applied into the conjunctival sac of the left eye of each rabbit. The untreated eye serves as control.

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: no adverse effect observed

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

72 h

Score:

0

Max. score:

0

Reversibility:

other: no adverse effect observed

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

48 h

Score:

0

Max. score:

0

Reversibility:

other: no adverse effect observed

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Remarks on result:

probability of mild irritation

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: no adverse effect observed

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: no adverse effect observed

Remarks on result:

no indication of irritation

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this test and the results obtained, it is concluded, that the test substance is not irritant to the eye.

Executive summary:

In order to assess the eye irritating potential of the test substance, 0.1 ml of the undiluted test item was applied into the conjunctival sac of the left eye of each of 3 rabbits. The untreated eye serves as control. After one hour the treated eye was washed. The assessment of possible effects to the eyes was performed with the assistance of a lamp 60 minutes, 24, 48 and 72 hours after application of test item. The eye reactions were assessed according to the numerical scoring system (acc. to Draize). The description of the degree and nature of irritation and the presence of serious damage were noted as follows:

- No mortality or signs of systemic toxicity occurred.

- Hyperemia was observed in two of three animals at the 24 hour time point (score 1 -1 -0). This effect was reversible within 48 hours.

- No Chemosis of the conjunctiva was observed in all animals 24, 48 and 72 hours after application (score 0-0-0).

- No Corneal opacity were observed in all three animals 24, 48 and 72 hours after application of the test substance (score 0-0-0).

- No effects at Iris was observed in all animals 24, 48 and 72 hours after application of the test substance (score 0-0-0).

Under the conditions of this test and the results obtained, it is concluded, that the test substance is not irritant to the eye.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

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.

Eye irritation:

In order to evaluate the eye irritation potential of the test substance one OCED 405 study in rabbits is available.For the study 0.1 mL of the test material was applied into one of each eye of three rabbits. 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. Two of three tested animals had a slight positive reaction of hyperemia with the test material at the 24 hour timepoint after start of treatment which was fully reversible within 48hours. No other reaction was observed in any rabbit during the observation period of 72 hours

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.