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Administrative data

Description of key information

The available information demonstrates no irritating effects on skin nor in eyes of rabbits.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
June 1992
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Padre Antonio - Mariano Comense, Italy
- Age at study initiation: no data
- Weight at study initiation: 2,5 - 3,5 kg
- Housing: stainless steel cages (4S0x500x380 mm) equipped with automatic washing cycle
- Diet: standard pellet complete diet supplied by the authorized breeder
- Water: filtered tap water from local network ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1992-06-01 To: 1992-06-08
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: sesame seed oil
Controls:
no
Amount / concentration applied:
500 mg test substance was turned to a paste with 0.5 mL of sesame seed oil
Duration of treatment / exposure:
4 h
Observation period:
24, 48 and 72 h after treatment
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 20 cm² of the right flank
- % coverage: no data
- Type of wrap if used: square gauze pad (2.5 x 2.5 cm) fixed to adhesive tape (Hansamed strips) , kept in plase by thin bands of adhesive hypoallergenic tape (Blenderm 3M), the entire trunk of the animal then wrapped with rubberized cloth (Acrylastic Beyersdorf AG , Hamburg)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, using a pad soaked in distilled water
- Time after start of exposure: 4 h

SCORING SYSTEM:
see Table #1 below
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0

Table #2: 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

Erythema

Edema

Max. score: 4

Max. score: 4

60 min

0/0/0/0/0/0

0/0/0/0/0/0 

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

Reversibility*)

 -

Average time (unit) for reversion

 -

-

 

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

 

Interpretation of results:
GHS criteria not met
Conclusions:
Under te conditions the test material 1,2,3-Propanetricarboxylic acid, 2-hydroxy-, tri-C14-15-alkyl esters can be considered non irritant.
Executive summary:

The test was performed by means of a single dose application of the test material 1,2,3-Propanetricarboxylic acid, 2-hydroxy-, tri-C14-15-alkyl esters on the skin of 6 albino male rabbits. The test material was applied to the shaved skin of 6 rabbits at a dose of 500 mg/rabbit for 4 hours, prepared as a paste with 0.5 ml of sesame seed oil. The animals were observed after the removal of the bandages and after 24, 48 and 72 hours for signs of erythema or oedema. During the study in all treated animals no erythema and edema were observed. Under test conditions the test material can be considered non irritant.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
June 1992
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to
Guideline:
other: Draize test
GLP compliance:
no
Species:
human
Details on test animals and environmental conditions:
38 volunteers were used for the study (15 males and 23 females) aged between 18 and 65 years.
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Controls:
other: non-treated area of skin
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
Duration of treatment / exposure:
48 h
Observation period:
15 minutes and 24 hours following the removal of the patches
Details on study design:
TEST SITE
- Area of exposure: 1 cm² on the back
- % coverage: no data
- Type of wrap if used: occlusive patch, no further details mentioned

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, using a pad soaked in distilled water
- Time after start of exposure: 48 h

SCORING SYSTEM:
see table #1 below
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48 and 72 h
Score:
0
Max. score:
8
Irritant / corrosive response data:
Erythema score (mean): 0
Oedema score (mean): 0
Interpretation of results:
GHS criteria not met
Conclusions:
The results of the study interpreted in accordance with Draize Method, indicate that the test material can be considered as non-irritant.
Executive summary:

The test was performed by means of a single dose application of the test material Cosmacol ECL on the skin of 38 volunteers (15 males, 23 females, aged between 18 and 65 years). Each volunteer served as its own control, having a treated and a non-treated area of skin. The test material was applied at dosis of 0.5 g in an area of about 1 cm² on the back by means of an occlusive patch. The patches were removed 48 hours after application and reactions evaluated 15 minutes and again 24 hours following the removal of patches. Skin irritation was scored according to Draize. No skin irritation (Erythema = 0, Edema = 0) was found in any of the volunteers and Cosmacol ECL was judged to be non-irritant.

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

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
June 1992
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Padre Antonio - Mariano Comense (CO), Italy
- Age at study initiation: no data
- Weight at study initiation: 2.5 - 3.5 kg
- Housing: singly in stainless steel cages (dimensions: 450x500x380 mm) equipped with automatic washing cycle
- Diet: standard pellet complete diet ad libitum
- Water: filtered tap water ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
Temperature and humidity were regulated by a conditioning plant and were continuously recorded, no further details mentioned
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 02-JUN-1992 To: 05-JUN-1992
Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
at 1, 24, 48 and 72 hours
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not washed

SCORING SYSTEM: according to guideline

TOOL USED TO ASSESS SCORE: no data
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0.22
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
2
Irritant / corrosive response data:
for details see table below

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

 0/0/0/0/0/0

 0/0/0/0/1/1

 0/0/0/0/0/0

24 h

 0/0/0/0/0/0

 0/0/0/0/0/0

 0/0/0/0/1/1

 0/0/0/0/0/0

48 h

 0/0/0/0/0/0

 0/0/0/0/0/0

 0/0/0/0/1/1

 0/0/0/0/0/0

72 h

 0/0/0/0/0/0

 0/0/0/0/0/0

 0/0/0/0/0/0

 0/0/0/0/0/0

Average 24h, 48h, 72h

 0

 0

 0.22

 0

Reversibility*)

 -

 -

 c.

 -

Average time for reversion

 -

 -

 72 h

 -

 

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

 

Interpretation of results:
GHS criteria not met
Conclusions:
The test material was not an eye irritant.
Executive summary:

An ocular irritation test was carried out on test material Cosmacol ECL according to OECD Guideline 405.

The test was performed by placing the test material in a single dose in the conjunctival sac of 6 albino male rabbits at a dose of 0.1 g/animal. The animals eyes were examined 1, 24, 48 and 72 hours after the beginning of the test. The ocular areas obvserved were the cornea, the iris and conjunctivae. The results showed a slight congestion of the conjunctivae in 2 of 6 rabbits treated. This irritation was seen one hour after the treatment, and disappeared 72 hours after treament.

It was concluded that Cosmacol ECL is to be considered non-irritant to eyes.

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1993
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
no guideline followed
Principles of method if other than guideline:
according to Luepke N.P. Hen's Egg Chorioallantoic Membrane Test for Irritation Potential. Fd. Chem. Toxicol. 23, 287-281 (1985)
The chorioallantoic membranes of fertilised chicken eggs were treated with aliquots of test materials directly on the surface and left in contact for 20 seconds, after which time they were washed away with warm sterile water. Observations of reaction in the CAM were made during a five minute period immediately after irrigation. The intensity of vascular injection, the extent of haemorrhage and the occurrence of coagulation of cytosolic proteins were assessed. Negative (sterile water) and positive control material (glacial acetic acid) was tested in parallel.
GLP compliance:
yes
Species:
other: fertilised chicken eggs
Strain:
other: Ross variety
Details on test animals or tissues and environmental conditions:
Day 10 fertilised chicken eggs of the Ross variety were obtained from Suffolk Sovereign Hatcheries, Eye, Suffolk on the morning of test commencment. The eggs were transported in a constant temperature carrier to minimise heat loss. The eggs were maintained in a humidified incubator at 39°C until later that day.
Vehicle:
unchanged (no vehicle)
Controls:
other: sterile water was tested as negative control
Amount / concentration applied:
approximately 100 mg
Duration of treatment / exposure:
20 sec
Observation period (in vivo):
during a 5 min period immediately after irrigation
Details on study design:
Preparation of CAMs:
A line was etched on the air sac end of each egg using a diamond marker pen. The tip of a pointed scllpel blade was used to make a small incision through the line. The shell was carfully chipped away, using small dissection scissors, to reveal the inner shell membrane. This was wetted with warm sterile water and gently peeled away from the delicate CAM beneath, using fine forceps. Excess water was poured off. Only undamaged, well formed CAMs were used in the test.

Treatment regime:
The test material was tested in triplicate: the material was applied as 200 µL aliquots directly to the CAM surface and left in contact with the membrane for 20 seconds, after which time they were washed away by irrigation with warm sterile water.

Observation and assessment: Observations of reaction in the CAM were made during a five minute period immediately after irrigation. The intensity of vascular injection, the extent of haemorrhage and the occurrence of coagulation of cytosolic proteins were assessed.

Scoring system and interpretation: see tables #1 and #2 below
Irritation parameter:
in vitro irritation score
Value:
0
Negative controls validity:
valid
Positive controls validity:
valid
Irritant / corrosive response data:
Irritant response data of the controls:
negative control (sterile water): 0, non-irritant (no reactions detected)
poasitive control (glacial acetic acid): 10, severe irritant (Fixation and discolouration of blood vessels)
Other effects:
During testing it was noted that the test material moved freely across the CAM surface when washed off. The test material may therefore have interacted with the CAM in a way different to that seen with other test materials. Non-wettable materials can be expected to interact in this different way, but the test material is understood to contain hydrophilic groups which should have ensured contact with the CAM despite the presence of the expected surface film of moisture. The physical nature of such interaction with the CAM can be expected to resemble the interaction which would occur if the same test material was placed in contact whti the moist outer surface of the mammalian eye.
Interpretation of results:
GHS criteria not met
Conclusions:
No reactions were detected in any egg treated with the test material. The test material showed no irritant effect in vitro, thus the CAM test predicts that the test substance Cosamcol ECL would be non-irritant in vivo.
Executive summary:

The test material Cosmacol ECL was tested in the CAM test, an in vitro prescreen for predicting in vivo ocular irritancy. The test also included negative (sterile water) and positive (glacial acetic acid) controls.

The chorioallantoic membranes of fertilised chicken eggs were treated with aliquots of test materials directly on the surface and left in contact for 20 seconds, after which time they were washed away with warm sterile water. Observations of reaction in the CAM were made during a five minute period immediately after irrigation. The intensity of vascular injection, the extent of haemorrhage and the ocurrence of coagulation of cytosolic proteins were assessed.

No reactions were detected in any egg treated with the test material Cosmacol ECL: thus the test material showed no irritant effect in vitro, and would be predicted to be non-irritant in vivo.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

A skin irritation test was performed by means of a single dose application of the target substance 1,2,3 -Propanetricarboxylic acid, 2 -hydroxy-, tris(C14 -15 -alkyl) ester, on the skin of 6 albino male rabbits.

The substance was applied to the shaved skin of the rabbits at a dose of 500 mg/rabbit for 4 hours, prepared as a paste with 0.5 ml of sesame seed oil. The animals were observed after the removal of the bandages and after 24, 48 and 72 hours for signs of erythema or oedema. During the study in all treated animals no erythema and edema were observed. Under test conditions the test material can be considered non-irritant.

The target substance was also tested in a human patch test. The results of the study interpreted in accordance with Draize Method, indicate that the test material can be considered as non-irritant. Also tests on the Source substances Tri(hexyl, octyl, decyl) citrate and the structurally related 1,2,3 -Propanetricarboxylic acid, 2 -hydroxy-, tris(C12 -13 -alkyl) ester showed no irritant effect.

An ocular irritation test was carried out on target substance 1,2,3 -Propanetricarboxylic acid, 2 -hydroxy-, tris(C14 -15 -alkyl) ester, according to OECD Guideline 405. The test was performed by placing the test material in a single dose in the conjunctival sac of 6 albino male rabbits at a dose of 0.1 g/animal. The animal eyes were examined 1, 24, 48 and 72 hours after the beginning of the test. The ocular areas observed were the cornea, the iris and conjunctivae. The results showed a slight congestion of the conjunctivae in 2 of 6 rabbits treated. This irritation was seen one hour after the treatment, and disappeared 72 hours after treatment. Also no reactions were detected in a CAM study with the target substance 1,2,3 -Propanetricarboxylic acid, 2 -hydroxy-, tris(C14 -15 -alkyl) ester: thus the test material showed no irritant effect in vitro, and would be predicted to be non-irritant in vivo. In studies according OECD 405 with the source substances Tri (hexyl, octyl, decyl) citrate and the structurally related substance 1,2,3 -Propanetricarboxylic acid, 2 -hydroxy-, tris(C12 -13 -alkyl) ester were also not seen irritation.

The available information demonstrates no irritating effects on skin nor in eyes of rabbits.

Justification for classification or non-classification

The available information demonstrates no irritating effects on skin nor in eyes of rabbits of the target substance

1,2,3 -Propanetricarboxylic acid, 2 -hydroxy-, tris(C14 -15 -alkyl) ester.

No classification for skin or eye irritation is indicated according to the general classification and labeling requirements for dangerous substances and preparations (Directive 67-548-EEC) or the classification, labeling and packaging (CLP) regulation (EC) No 1272/2008.