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Description of key information

The skin sensitization potential of the test substance ‘oils, vegetable, deodorizer distillates’ can be deduced based on information available on the individual constituents. Studies conducted on glycerides, fatty acids and the various components of unsaponifiable matter (e.g. tocopherols, sterols, sterol esters and squalene) suggest that these constituents are not likely to cause skin sensitization in animals or humans.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Principles of method if other than guideline:
The skin sensitization potential of the constituent palm oil was evaluated in the Magnusson-Kligman maximization test. The induction phase consisted of intradermal injection of 5% palm oil followed by epicutaneous application of 100% palm oil as booster. All the groups were challenged with 0.5 mL 5% palm oil. Reactions were observed 24 and 48 h after patch removal.
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Conducted prior to the mandate of in vitro test requirement
Species:
guinea pig
Strain:
Hartley
Sex:
female
Route:
intradermal and epicutaneous
Vehicle:
propylene glycol
No. of animals per dose:
10 animals in both control and test groups
Details on study design:
INDUCTION:
During the induction, 3 pairs of sites per animals in the test group were injected with following materials:
5% palm oil in propylene glycol
5% palm oil in 50% aqueous Freund's Complete Adjuvant
50% Freund's Complete Adjuvant
Each material (0.5 mL) was injected intradermally.
In the booster phase, initiated 1 wk after induction, an occlusive dressing pad containing full strength palm oil (0.5 mL) was applied on the induction injection sites on each animal in the test group.

CHALLENGE:
2 wks after the booster phase, animals in first and second test groups were challenged with 0.5 mL 5% palm oil. Patches were applied to previously untreated sites and remained in place for 24 h. Reactions were observed 24 and 48 h after patch removal.

SCORING:
Following scale was used during the observation of skin sensitization:
0 (no evidence of any effects) to 4 (severe, deep red erythema with vesiculation or weeping with or without edema).
Challenge controls:
The three pairs of sites on each control animal were injected intradermally with undiluted propylene glycol, 1:1 propylene glycol: 50% aqueous Freund's Complete Adjuvant, 50% aqueous Freund's Complete Adjuvant respectively, during induction. 1 wk after induction, a full strength petrolatum (booster) was applied according to the same procedure as in the test group.
Positive control substance(s):
not specified
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No data
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No data
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Group:
negative control
Dose level:
No details given
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No details given
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Group:
positive control
Dose level:
No details given
No. with + reactions:
0
Total no. in group:
0
Clinical observations:
No details given
Remarks on result:
positive indication of skin sensitisation
Interpretation of results:
study cannot be used for classification
Conclusions:
Under the test conditions, 5% of the substance was found to be non-sensitizing to guinea pigs.
Executive summary:

A study was conducted to determine the skin sensitization potential of the constituent ‘glycerides, C16 -18 and C18 -unsatd.’ (as palm oil) according to the Magnusson-Kligman maximization test, using three groups of 10 female guinea pigs of the Hartley strain. In the induction phase, the test group was injected with: 5% substance in propylene glycol, 5% substance in 50% aqueous Freund's Complete Adjuvant and 50% Freund's Complete Adjuvant. In the booster phase, the undiluted substance (0.5 mL) was applied occlusively. Two of the groups served as controls. All the groups were challenged with 0.5 mL of 5% substance. Reactions were observed 24 and 48 h after patch removal. No reactions were observed in any of the tested group. Under the test conditions, 5% substance was found to be non-sensitizing to guinea pigs (CTFA, 1978).

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Principles of method if other than guideline:
The procedure was based on, and similar to, the method described by Magnusson and Kligman, 1970 (Skin sensitizing: Guinea pig maximization test).Induction phase consisted of intradermal injection of 5% soybean oil followed by epicutaneous application of 100% soybean. 50% soybean oil was applied epicutaneously during challenge phase.
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Conducted prior to the mandate of in vitro test requirement
Species:
guinea pig
Route:
intradermal and epicutaneous
Vehicle:
no data
Concentration / amount:
Injection: 5% and Application: 100%
Route:
other: epicutaneous
Vehicle:
no data
Concentration / amount:
50%
No. of animals per dose:
10
Details on study design:
The procedure was based on the method described by Magnusson and Kligman, 1970.
Positive control substance(s):
not specified
Key result
Reading:
other: Readings after three challenges
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
Not reported
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Group:
negative control
Dose level:
No details given
No. with + reactions:
0
Total no. in group:
0
Clinical observations:
No details given
Remarks on result:
other: No details given
Key result
Reading:
1st reading
Group:
positive control
Dose level:
No details given
No. with + reactions:
0
Total no. in group:
0
Clinical observations:
No details given
Remarks on result:
other: No details given
Interpretation of results:
study cannot be used for classification
Conclusions:
Under the test conditions, the substance was determined to be non-sensitizing to guinea pig skin.
Executive summary:

A study was conducted to evaluate the skin sensitisation potential of the constituent soybean oil in guinea pigs. The procedure was based on the maximisation method described by Magnusson and Kligman, 1970. Induction phase consisted of intradermal injection of 5% of the substance followed by epicutaneous application of undiluted substance. 50% of the substance was applied epicutaneously during challenge phase. 0/10 guinea pigs were sensitized after 3 challenges. Under the test conditions, the substance was determined to be a non-sensitizing to guinea pig skin (Unilever Research, 1982).

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Qualifier:
no guideline followed
Principles of method if other than guideline:
Skin sensitization potential of the constituent coconut oil was determined in guinea pigs using Magnusson-Kligman maximization procedure.
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Conducted prior to the mandate of in vitro test requirement
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Route:
intradermal and epicutaneous
Vehicle:
other: propylene glycol
Concentration / amount:
Induction: 5% and Booster: 100%
Route:
epicutaneous, occlusive
Vehicle:
other: propylene glycol
Concentration / amount:
Challenge: 50 and 100%
No. of animals per dose:
10 animals both in test and control groups
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
Test animals: received two injections of each of the following in separate locations on the back:
1) 50% aqueous Freund’s complete adjuvant
2) 5% coconut oil in propylene glycol
3) 5% coconut oil in 50% Freund’s complete adjuvant
Control animals: received the same treatment regimen of vehicles only.

B. BOOSTER EXPOSURE
Test animals: 1 wk after induction, 5% sodium lauryl sulfate in petrolatum was applied to each induction site. 24 h later, a topical booster of 100% coconut oil was applied to the same sites.
Control animals: received 5% sodium lauryl sulfate in petrolatum and, 24 h later, full strength petrolatum as a booster. All control and test animals were wrapped occlusively for 48 h.

C. CHALLENGE EXPOSURE
2 wks after the topical booster, the animals were challenged with topical applications of 50% and 100% coconut oil via 24 h occlusive patch. The challenge sites were graded 48 and 72 h after the beginning of the challenge.
Challenge controls:
Same treatment as used for test group but using only the vehicle
Positive control substance(s):
not specified
Key result
Reading:
other: not reported
Hours after challenge:
48
Group:
test chemical
Dose level:
50 and 100%
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
other: not reported
Hours after challenge:
72
Group:
test chemical
Dose level:
50 and 100%
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Group:
negative control
Dose level:
No details given
Clinical observations:
No details given
Remarks on result:
other: No details given
Key result
Reading:
1st reading
Group:
positive control
Dose level:
No details given
No. with + reactions:
0
Total no. in group:
0
Clinical observations:
No details given
Remarks on result:
other: No details given

Coconut oil was non-irritating and failed to produce an allergic response (no further details reported).

Interpretation of results:
study cannot be used for classification
Conclusions:
Under the test conditions, the substance was not found to be sensitizing to guinea pig skin.
Executive summary:

A study was conducted to determine the skin sensitisation potential of the constituent ‘Glycerides, C8 -18 and C18 -unsatd.’ (as coconut oil) in guinea pigs using the Magnusson-Kligman maximization procedure. 10 test animals and 10 controls were used in the induction, booster, and challenge phases. Induction was done by intradermal injection of 5% the test substance with Freund’s complete adjuvant. 1 wk after induction, 5% sodium lauryl sulfate in petrolatum was applied to each induction site. 24 h later, a topical booster of 100% test substance was applied to the same sites. 2 wks after the topical booster, the animals were challenged with topical applications of 50% and 100% test substance. Sites were graded after 48 and 72 h of challenge application. Coconut oil was non-irritating and failed to produce an allergic response. Under test conditions, the test substance was found to be non-sensitizing to guinea pig skin (CIR, 1986).

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
Not available
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Qualifier:
no guideline followed
Principles of method if other than guideline:
Skin sensitization potential of the constituent fully hydrogenated coconut oil was determined in guinea pigs using Buehler method.
GLP compliance:
not specified
Type of study:
Buehler test
Justification for non-LLNA method:
Conducted prior to the mandate of in vitro test requirement
Species:
guinea pig
Sex:
male/female
Route:
epicutaneous, occlusive
Vehicle:
other: 95% ethyl alcohol
Concentration / amount:
5%
Route:
epicutaneous, occlusive
Vehicle:
other: 95% ethyl alcohol
Concentration / amount:
5%
No. of animals per dose:
15 in test group and 5 in control group
Details on study design:
RANGE FINDING TESTS: The primary irritation threshold for fully hydrogenated coconut oil was found to be 5% in ethyl alcohol, which produced slight irritation upon repeated application.


MAIN STUDY
A. INDUCTION EXPOSURE
An occlusive Webril pad containing 0.5 mL of the 5% fully hydrogenated coconut oil in ethyl alcohol was applied for 6 h to the shaved backs. This procedure was repeated three times weekly for a total of nine induction applications.

B. CHALLENGE EXPOSURE
Two wks after the last prechallenge application, all animals were challenged topically on untreated sites with the same procedure for application and
dosage employed previously. Skin reactions were graded 24 h after the challenge.

Challenge controls:
Same treatment as used for test group but using only the vehicle
Positive control substance(s):
not specified
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
5%
No. with + reactions:
0
Total no. in group:
15
Clinical observations:
No data
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No data
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Group:
positive control
Dose level:
No details given
No. with + reactions:
0
Total no. in group:
0
Clinical observations:
No details given
Remarks on result:
other: No details given
Interpretation of results:
study cannot be used for classification
Conclusions:
Under the test conditions, the substance was found to be non-sensitizing to guinea-pig skin.
Executive summary:

A study was conducted to determine the skin sensitisation potential of the constituent ‘Glycerides, C8-18 and C18-unsatd.’ (as fully hydrogenated coconut oil) in guinea pigs according to the Buehler method. An occlusive Webril pad containing 0.5 mL of 5% substance in ethyl alcohol was applied for 6 h to the shaved backs of 15 guinea pigs. This procedure was repeated three times weekly for a total of nine induction applications. A control group of 5 animals was subjected to the same treatment using only the vehicle, 95% ethyl alcohol. Two weeks after the last prechallenge application, all animals were challenged topically and skin reactions were graded after 24 h. No animals developed skin responses significantly greater than the controls. Under the test conditions, the substance was found to be non-sensitizing to guinea-pig skin (CIR, 1986).

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Reason / purpose for cross-reference:
reference to other study
Principles of method if other than guideline:
A patch test was conducted on an unspecified number of human subjects with both pure squalene and the un-saponifiable matter from shark liver oil containing 76% squalene.
GLP compliance:
not specified
Type of study:
patch test
Justification for non-LLNA method:
Conducted prior to the mandate of in vitro test requirement
Species:
human
Route:
epicutaneous, open
Vehicle:
no data
Concentration / amount:
Undiluted and 76%
Route:
epicutaneous, open
Vehicle:
no data
Concentration / amount:
Undiluted and 76%
Key result
Reading:
other: After single exposure to test material
Hours after challenge:
72
Group:
test chemical
Dose level:
76 and 100%
No. with + reactions:
0
Clinical observations:
no detectable effect upon the skin or hairs; no change in the degree of pigmentation occurred, nor was any effect on keratinisation observed
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Group:
negative control
Dose level:
No details given
No. with + reactions:
0
Total no. in group:
0
Clinical observations:
No details given
Remarks on result:
other: No details given
Key result
Reading:
2nd reading
Group:
positive control
Dose level:
No details given
No. with + reactions:
0
Total no. in group:
0
Clinical observations:
No details given
Remarks on result:
other: No details given

Additional skin sensitisation study of Puhvel and Sakamoto, 1977 cited in the CIR review report, indicate similar negative results, on intradermal exposure to 50 µg of squalene in 29 human subjects.

Study details:

Squalene was injected intradermally at a dose of 50 µg into 29 subjects and visually inspected after 24 and 48 h. Control injections consisted of physiologic saline containing 0.05 % polysorbate 80. Histological examination of the biopsies were also investigated after 24 h.

 

Upon visual inspection after 24 and 48 h, the sites of injection were normal and there was no erythema, induration, or inflammatory skin lesions in any of the subjects. Histological examination of biopsies taken at 24 h demonstrated the presence of a mild, predominantly lymphocytic, perivascular infiltration which was only slightly more intense than the reaction induced by control injections.

 

Hence, under the test conditions, squalene was not found to produce significant sensitization effects on skin.

Interpretation of results:
study cannot be used for classification
Conclusions:
Under the test conditions, no contact sensitisation effects were found on exposure to neat and 76% of the substance.
Executive summary:

A patch test was conducted on an unspecified number of human subjects with both pure squalene and an un-saponifiable matter from shark liver oil containing 76% squalene. The substances were each left in contact with the intact skin for 72 h. There was no detectable effect upon the skin or hairs; no change in the degree of pigmentation occurred, nor was any effect on keratinisation observed. Under the test conditions, no contact sensitisation effects were found on exposure to pure and 76% of test substance. Similar negative results, on intradermal exposure to 50 µg of the substance in 29 human subjects, were obtained in an additional skin sensitisation study of Puhvel and Sakamoto (1977) cited in the CIR report (CIR, 1982).

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Reason / purpose for cross-reference:
reference to other study
Qualifier:
no guideline followed
Principles of method if other than guideline:
Method followed unknown, data from SCF opinion

GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Conducted prior to the mandate of in vitro test requirement
Species:
guinea pig
Key result
Reading:
1st reading
Hours after challenge:
0
Group:
test chemical
Dose level:
Not specified
No. with + reactions:
0
Total no. in group:
0
Clinical observations:
Not specified
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
0
Group:
negative control
Dose level:
Not specified
No. with + reactions:
0
Total no. in group:
0
Clinical observations:
Not specified
Remarks on result:
other: Not specified
Key result
Reading:
1st reading
Hours after challenge:
0
Group:
positive control
Dose level:
Not specified
No. with + reactions:
0
Total no. in group:
0
Clinical observations:
Not specified
Remarks on result:
other: Not specified

β-Sitosterol lacks sensitisation potential in a guinea pig maximization test.

Interpretation of results:
study cannot be used for classification
Conclusions:
Under the test conditions, the substance was found to be non-sensitizing in a Guinea Pig Maximisation Test (GPMT).

Executive summary:

According to the Scientific Committee on Food (SCF), tall oil-derived “ β-Sitosterol” preparation was found to be non-sensitizing in a Guinea Pig Maximisation Test (GPMT).

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Reason / purpose for cross-reference:
reference to other study
Principles of method if other than guideline:
The sensitisation potential of a mixture containing <0.1% tocopherol was evaluated in an open epicutaneous test using ten Pirbright white guinea pigs.
GLP compliance:
not specified
Type of study:
open epicutaneous test
Justification for non-LLNA method:
Conducted prior to the mandate of in vitro test requirement
Species:
guinea pig
Strain:
Pirbright-Hartley
Route:
epicutaneous, open
Vehicle:
other: not specified
Concentration / amount:
0.1%
Route:
epicutaneous, open
Vehicle:
other: not specified
Concentration / amount:
0.1%
No. of animals per dose:
Ten animals in test group and five in control
Positive control substance(s):
not specified
Key result
Reading:
other: after challenge
Hours after challenge:
48
Group:
test chemical
Dose level:
0.1% tocopherol
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No signs of irritation was observed
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Group:
positive control
Dose level:
no details given
No. with + reactions:
0
Total no. in group:
0
Clinical observations:
no details given
Remarks on result:
other: no details given
Key result
Reading:
2nd reading
Group:
negative control
Dose level:
no details given
No. with + reactions:
0
Total no. in group:
0
Clinical observations:
no details given
Remarks on result:
other: no details given
Interpretation of results:
study cannot be used for classification
Conclusions:
Under the test conditions, a mixture containing <0.1% of the substance was not a sensitiser.
Executive summary:

A study was conducted to investigate the sensitisation potential of a mixture containing <0.1% tocopherol in an open epicutaneous test using ten Pirbright white guinea pigs.

A group of five guinea pigs was used as a control. The hair on the left side of the back was clipped, and 0.5 mL of the mixture containing the substance was applied to the test site daily for 10 d. Following a non-treatment period of 14 d, the substance was applied to a previously untreated site of both test and control animals. The test sites were scored according to the method of Draize, 24 and 48 h after application of the challenge dose. Signs of irritation were not observed following challenge. Under the test conditions, a mixture containing <0.1% of the substance was not a skin sensitiser (Fiume, 2002 (1)).

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Reason / purpose for cross-reference:
reference to other study
Qualifier:
no guideline followed
Principles of method if other than guideline:
The skin sensitization potential of a cream containing 5% of the constituent tocopherol was determined in a repeat-insult patch test (RIPT) using 113 subjects (35 males and 78 females).
GLP compliance:
not specified
Type of study:
patch test
Justification for non-LLNA method:
Conducted prior to the mandate of in vitro test requirement
Species:
human
Sex:
male/female
Route:
epicutaneous, semiocclusive
Vehicle:
other: cream
Concentration / amount:
0.2 mL of 5% tocopherol
Route:
epicutaneous, semiocclusive
Vehicle:
other: cream
Concentration / amount:
0.2 mL of 5% tocopherol
No. of animals per dose:
113 subjects (35 males and 78 females)
Key result
Reading:
other: challenge
Hours after challenge:
48
Group:
test chemical
Dose level:
0.2 mL of 5% of tocopherol
No. with + reactions:
0
Total no. in group:
113
Clinical observations:
Not reported
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Group:
negative control
Dose level:
No details given
No. with + reactions:
0
Total no. in group:
0
Clinical observations:
No details given
Remarks on result:
other:
Key result
Reading:
2nd reading
Group:
positive control
Dose level:
No details given
No. with + reactions:
0
Total no. in group:
0
Clinical observations:
No details given
Remarks on result:
other: No details given
Interpretation of results:
study cannot be used for classification
Conclusions:
Under the test conditions, a cream containing 5% of the substance was assessed not to be skin sensitizer.
Executive summary:

A study was conducted to determine the skin sensitization potential of a cream containing 5% of the constituent tocopherol in a repeat-insult patch test (RIPT) using 113 human subjects (35 males and 78 females). A semi-occlusive patch containing 0.2 mL of the substance was applied for 24 h to the upper back of each subject three times per week for a total of 10 applications. The test sites were scored prior to each application. After a 2-week non-treatment period, the challenge was performed by applying the substance to the original site and a previously untreated site on the volar forearm. These sites were evaluated 24 and 48 h after application. Under the test conditions, a cream containing 5% of the substance was assessed not to be skin sensitizer (Fiume, 2002 (2)).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

There is no published information on the skin sensitisation potential of ‘oils, vegetable, deodorizer distillates’ in animals or humans. However, data is available for its constituents:

The following key points can be sumamrised based on the available studies:

Glycerides:

·        When tested in guinea pig skin sensitisation tests according to the Buehler or maximisation test protocols, glycerides with chain lengths between C8 -18 or C16 -18, including C18 -unsatd., did not show any signs of skin sensitisation (CIR, 1986; CIR, 2000; IUCLID, 2000).

·        Studies conducted with glycerides of chain lengths between C16 and C18, including C18-unsatd., showed no indication of skin sensitization in human volunteers (CIR, 2000; Bush et al.,1985; Cuthbert and Neilson, 1996; CIR, 2001a). This is supported by the long history of safe use of these types of substances in cosmetic and industrial applications in which substantial skin contact may occur.

Fatty acids:

·        No animal studies could be found on fatty acids themselves but Magnusson and Kligman GPMT tests conducted using two different types of mixed fatty acid sodium salts demonstrated no skin sensitisation potential (HERA, 2002).

·        In a skin sensitisation study with 28 volunteers, five 48 h covered applications of 1% decanoic acid (C10) in petrolatum were made over a 10 -d period. There were no positive reactions when challenged 10 -14 d after the induction phase with a final 48 d closed patch test using 1% in petrolatum. No local reactions indicative of sensitisation were seen in 100 subjects patch tested [under unspecified conditions] with a bath soap and detergent formulation containing 0.3-0.75% sodium stearate. Another study reported that 25 subjects showed no sensitisation reactions when exposed to 5% stearic acid (C18) in petrolatum and a 1% aqueous sodium stearate solution (HERA, 2002).

UMs:

·        Tocopherols, sterols, sterol esters and squalene are generally not sensitizing in animal studies (Fiume, 2002; SCF, 2003; CIR, 1982).

·        Tocopherols and squalene were not sensitizing in human patch tests (Fiume, 2002; CIR, 1982). No information was found regarding sterols and sterols esters.

Overall, the weight of evidence from the different constituents suggests that ‘oils, vegetable, deodorizer distillates’ is not sensitising to skin.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

Under normal atmospheric conditions, exposure to ‘oils, vegetable, deodorizer distillates’ via the inhalation route is limited given its low vapour pressure (0.0328 Pa at 20°C). Further, the inhalation exposure potential in workers where the substance is handled in aerosolized or spray form is considered to be low due to implementation of strict risk management measures at workplace (see sections 9 and 10 of the CSR). Nevertheless, based on the absence of skin sensitisation potential and the long history of safe use of the individual constituents, the respiratory sensitisation potential of the test substance is not expected to pose an issue for human health. Hence, no further testing was conducted, in accordance with Annex XI (1.1) of the REACH regulation.

Justification for classification or non-classification

The skin sensitization potential of the test substance ‘oils, vegetable, deodorizer distillates’ can be deduced based on information available on the individual constituents. Studies conducted on glycerides, fatty acids and the various components of unsaponifiable matter (e.g. tocopherols, sterols, sterol esters and squalene) suggest that these constituents are not likely to cause skin sensitization in animals or humans. 

Exposure via the inhalation route is not expected to be significant considering the low vapour pressure of the substance. Further, the inhalation exposure potential in workers where the substance is handled in aerosolized or spray form is considered to be low due to implementation of strict risk management measures at workplace (See sections 9 and 10 of the CSR). Nevertheless, based on the absence of skin sensitisation potential and the long history of safe use of the individual constituents, the respiratory sensitisation potential of the test substance is not expected to pose an issue for human health.

Based on the above information, ‘oils, vegetable, deodorizer distillates’ does not warrant any classification for sensitization according to the CLP Regulation EC/1272/2008.