Registration Dossier

Administrative data

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.