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Description of key information

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:
May 1997 - June 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
other: Small White Russian
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Mollegaard Breeding/Research Centre Ltd., Denmark
- Age at study initiation: adult, no further details mentioned
- Weight at study initiation: 1.8 - 2.6 kg
- Housing: single housing in stainless steel cages
- Diet (e.g. ad libitum): Ssniff K4 complete feed for rabbits, ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): Drinking water ad libitum, supplied by Gelsenwasser, Wasserwerk Haltern, Germany
- Acclimation period: 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1997-05-26 To: 1997-06-06
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 cm³
Duration of treatment / exposure:
4 hours
Observation period:
up to 10 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm² of shaved skin of the dorsal part of the trunk of the animals
- % coverage: not mentioned
- Type of wrap if used: on the application area a mull patch was placed, which was covered with non-irritant plaster and held in place with a semi-occlusive 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:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
4.89
Max. score:
8
Reversibility:
fully reversible within: 10 days
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 10 d
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 10 d
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 10 d
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 6 d
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
fully reversible within: 8 d
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 6 d
Irritant / corrosive response data:
AVERAGE SCORE
- Erythema: 2.33
- Edema: 2.56
Other effects:
yellowish discoloration in the application area up to 72 hours, scales on the skin at day 6, detaching at day 8

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:

Max. score:

60 min

2/2/1

 1/2/2

24 h

2/3/2

 2/4/2

48 h

 2/3/2

 2/4/2

72 h

 2/3/2

 1/4/2

Average 24h, 48h, 72h

2.33 

 2.56

Reversibility*)

 c.

 c.

Average time (unit) for reversion

 10 days

 10 days

 

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

 

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
Coconut oil, reaction products with polyethylene glycol and trimethylolpropane was determined to be irritating to rabbit skin under the described conditions. The mean values were as follows:
- Erythema: 2.33
- Edema: 2.56
Executive summary:

The acute skin irritant effect on rabbits by Coconut oil, reaction products with polyethylene glycol and trimethylolpropane was tested according to OECD Guidelines for Testing of Chemicals, Section 4, No. 404, "Acute Dermal Irritation/corrosion" OECD 1992.

The test substance was tested on three animals using an exposure time of 4 hours. The liquid test substance (0.5 cm³ in each case) was applied in a single dose to shorn intact skin.

Administration of the test substance led as soon as 24 hours after removing the patches in the case of one of three animals to severe skin irritation in the form of severe erythema and oedema. These symptoms of severe skin irriation were observable up to 72 hours after removing patches and had completely disappeared by the 10th day of the study.

In two animals during this observation period, well-defined erythema and oedema were observed on the skin, with only very slight oedema still being observable on the skin of one animal 72 hours after removing the dressing.

On the 6th day, in one of three animals, well-defined erythema and slight oedema were observed, whereas in two animals only very slight erythema was observed on the skin. These symptoms of skin irritation had completely disappeared on the 10th day for all animals.

24 to 72 hours after removing patches, the skin of one animal had a yellowish discoloration at the point of application, which showed the most severe symptoms of skin irritation. All three animals exhibited scales on the skin on the 6th day, which had completely detached by the 10th day of the study.

The mean values were calculated from the numerically scored individual findings of observations made 24, 48 and 72 hours after the end of the exposure time:

-Erythema and eschar formation: 2.33

-Oedema formation: 2.56

Coconut oil, reaction products with polyethylene glycol and trimethylolpropane was judged to be irritating to rabbit skin under the conditions of this study.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
August 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Please see Analogue Approach
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
other: Small White Russian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach, Germany
- Age at study initiation: adult, no further details mentioned
- Weight at study initiation: 2.4 - 2.7 kg
- Housing: conventional, singly in stainless steel cages
- Diet (e.g. ad libitum): K4 complete feed for rabbits ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): Drinking water ad libitum
- Acclimation period: 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 1994-08-08 To: 1994-08-12
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 application
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm phyiological saline
- Time after start of exposure: 24 hours


SCORING SYSTEM: according to guideline


TOOL USED TO ASSESS SCORE: ophthalmic lamp, fluorescein solution 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 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
3
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:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
see table below
Other effects:
1 hour after application the treated eyes showed distinct injections of some conjuctival vessels, cornea and iris showed no effects. After 24 hours the conjuctivae were free of symptoms.

Table: Irritant/corrosive response data for each animal at each observation time 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

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:
The following mean values, based on the results from the 24 -, 48 - and 72 hour-readings were calculated:
Cornea opacity: 0.0
Iris lesion: 0.0
Redness of conjuntiva: 0.0
Oedema of conjunctiva: 0.0
Executive summary:

To test the acute irritant effect of coconut oil, reaction products of coconut fatty acid mono- or diglyceride with trimethylolpropaneethoxylate on the eyes and mucosa, 0.1 cm³ of the liquid test substance was administered into the conjunctival sac of one eye of each of three male rabbits. After exposoure for 72 hours, the eyes were washed out with warm physiological saline. The test was carried out according to OECD guideline 405 (24 Feb 1987).

The test showed that administration of coconut oil, reaction products of coconut fatty acid mono- or diglyceride with trimethylolpropaneethoxylate caused no irritation reactions.

The following mean values, based on the results from the 24 -, 48 - and 72 hour-readings were calculated:

Cornea opacity: 0.0

Iris lesion: 0.0

Redness of conjuntiva: 0.0

Oedema of conjunctiva: 0.0

Based on the result of this study coconut oil, reaction products of coconut fatty acid mono- or diglyceride with trimethylolpropaneethoxylate was judged to be non irritating to eyes and mucosa.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Coconut oil, reaction products with polyethylene glycol and trimethylolpropane was judged to be irritating to the skin and not irritating to the eye.

The structurally related substance coconut oil, reaction products of coconut fatty acid mono- or diglyceride with trimethylolpropaneethoxylate was not irritating to the eye. It is likely that also the test substance is not eye irritating because of the structural similarity (Please see Analogue Approach).




Justification for classification or non-classification

Coconut oil, reaction products with polyethylene glycol and trimethylolpropane was judged to be irritating to rabbit skin. Therefore it is classified into skin irritant categorie 2 (H315).

The structurally related substance coconut oil, reaction products of coconut fatty acid mono- or diglyceride with trimethylolpropaneethoxylate was not irritating to the eye. It is likely that also the test substance is not eye irritating and is therefore not classified as an eye irritant.