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Description of key information

In a reliable in vivo skin irritation study the substance was applied (0.5g) to the shaved skin of New Zealand White rabbits (3 animals) for a duration of 4 hours (semi-occlusive). The substance is considered to be slightly irritating to skin, but does not meet the requirements for classification under CLP.

In a reliable in vivo eye irritation study the substance was applied (0.1g) to the eye of New Zealand White rabbits (3 animals) for a duration of 24 hours. The substance is considered to be not irritating to the eye.

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:
1996-03-11 to 1996-03-26
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Age at study initiation: adult, no further details mentioned
- Weight at study initiation: 3 - 4.4 kg
- Housing: conventionally, singly in stainless steel cages
- Diet (e.g. ad libitum): Ssniff K 4- Complete feed for rabbits, supplied by Ssniff, Soest, Germany, ad libitum
- Water (e.g. ad libitum): Drinking water ad libitum, supplied by Gelsenwasser, Wasserwerk, Haltern, Germany
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: an adjacent area of untreated skin
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): undiluted
Duration of treatment / exposure:
4 hours
Observation period:
30-60 minutes, 24, 48 and 72 hours, 6, 8, and 14 days after patch removal
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: approx. 6 cm²
- % coverage: not mentioned
- Type of wrap if used: gauze patch covered with a non-irritant plaster and a semiocclusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to OECD Guideline 404
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
1.11
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
/mean
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
/mean
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
/mean
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
/mean
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
/mean
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within:
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
/mean
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritant / corrosive response data:
AVERAGE SCORE
- Erythema: 1.67
- Edema: 1.11
Other effects:
The following effects were noted:
2-3 days: slightly oedema
day 8:light brown discoloration and dryness of skin.
day 10: subsided irritations

Table: Irritant/corrosive response data for each animal at each observation time of each animal from the test

Score at time point / Reversibility

Erythema

Edema

Max. score: 4

Max. score: 4

30 - 60 min

2/2/2

 2/1/1

24 h

 2/2/2

 1/1/2

48 h

1/2/1

 1/1/1

72 h

 1/2/2

 1/1/1

Average 24h, 48h, 72h

 1.67

 1.11

Reversibility*)

c. 

 c.

Average time (unit) for reversion

 14 days

14 days 

 

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

 

Interpretation of results:
not irritating
Conclusions:
The test substance is slightly irritating but does not warrant classification according to CLP.
Executive summary:

Dermal irritation of the test substance (CAS 9174 4-23-9, Glyceryl Citrate/Lactate/Linoleate/Oleate) was investigated in a study according to OECD 404 and GLP. 0.5 g of the test substance were applied to the shaved skin of three New Zealand White rabbits (semi-occlusive coverage). Total exposure was 4 h. Thereafter, the test substance was removed using warm water.

Observations were made after 30-60 minutes, 24, 48, and 72 h, as well as 6, 8, and 14 days after patch removal. An adjacent area of untreated skin served as control.

Mean erythema and edema scores after 24, 48, and 72 h were 1.67 and 1.11, respectively. Both were fully reversible within 14 days.

Based on the results of this test the substance is slightly irritating but does not warrant classification according to CLP.

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:
1996-03-18 to 1996-03-22
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study.
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Age at study initiation: young adult, no further details mentioned
- Weight at study initiation: 2.8 - 3.8 kg
- Housing: conventional, singly in stainless steel cages
- Diet (e.g. ad libitum): Ssniff K4 - Complete feed for rabbits, supplied by Ssniff, Spezialfutter GmbH, Soest, Germany, ad libitum
- Water (e.g. ad libitum): Drinking water ad libitum, supplied by Gelsenwasser, Wasserwerk, Haltern, Germany
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 cm³
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
1, 24, 48 and 72 hours after administration
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm physiological saline
- Time after start of exposure: 24 hours

SCORING SYSTEM: according to OECD Guideline 405

TOOL USED TO ASSESS SCORE: ophthalmic lamp, fluorescein 24 hours after administration
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
/mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
/mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
/mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
/mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
/mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
/mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
/mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
/mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
/mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
/mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
/mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
/mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
AVERAGE SCORE
- Cornea: 0.0
- Iris: 0.0
- Conjuntivae (Redness): 0.0
- Conjuntivae (Chemosis): 0.0
Other effects:
marked hyperaemias of some blood vessels in all animals one hour after application, after 24 hours no effects was noticed.

Table #: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility

Cornea

Iris

Conjunctivae

Chemosis

Max. score: 4

Max. score: 2

Max. score: 3

Max. score: 4

60 min

0/0/0

0/0/0

1/1/1

0/0/0 

24 h

0/0/0 

0/0/0

0/0/0

0/0/0

48 h

0/0/0

0/0/0

0/0/0

0/0/0

72 h

0/0/0

0/0/0

0/0/0

0/0/0

Average 24h, 48h, 72h

0

0

0

0

Area effected

 -

-

-

-

Maximum average score (including area affected, max 110)

 0

0

 0

0

Reversibility*)

 -

-

-

-

Average time (unit) for reversion

 -

 -

 -

 -

 

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

 

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of this test the test item is not irritating to the eye.
Executive summary:

Eye irritation of the test substance (CAS 91744-23-9, Glyceryl Citrate/Lactate/Linoleate/Oleate) was investigated in a study according to OECD 405 and GLP. 0.1 cm³ of the test substance were instilled in one eye each of the three New Zealand White rabbits. Total exposure was 24 h. Thereafter, the test substance was removed using warm physiological saline.

Observations were made after 1, 24, 48, and 72 h after administration. The untreated eye of each animal served as control.

Marked hyperaemias of some blood vessels could be observed in all animals 1 h after application, after 24 hours no effects was noticed. Mean scores for cornea, iris, conjunctivae redness and conjunctivae chemosis after 24, 48, and 72 h were 0 for each endpoint.

Based on the results of this test the substance is classified as not irritating.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Based on the findings of a reliable in vivo skin irritation and eye irritation studies in New Zealand White rabbits, classification of the substance is not justified.