Fatty acids, lanolin, lithium salts

Endpoint summary

Description of key information

Dilithium adipate and fatty acids, lanolin are considered not to be skin sensitising substances.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Reference 1

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study is carried out in accordance to OECD guideline 429, EU method B.42 and is GLP compliant. Therefore, it is given reliability rating of 1 (reliable without restrictions).

Justification for type of information:

REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'.

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

according to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

Guideline:

EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)

GLP compliance:

yes (incl. QA statement)

Type of study:

other: Local Lymph Node Assay

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: Approximately 10 weeks old
- Weight at study initiation: Body weight variation was within +/- 20% of the sex mean.
- Housing: Makrolon cages containing sterilised sawdust
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24
- Humidity (%): 40-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:

acetone/olive oil (4:1 v/v)

Concentration:

2, 15 and 30 % test item w/w

No. of animals per dose:

5

Details on study design:

RANGE FINDING TESTS: 15 and 30 % test item w/w using 2 animals per concentration

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 days
- Test groups: 5 animals exposed to each concentration
- Control group: 5 animals exposed to the vehicle
- Site: dorsal surface of both ears
- Frequency of applications: Days 1, 2, 3
- Duration: 6 days
- Concentrations: 2, 15 and 30 % test item w/w

SCORE:
Erythema and eschar formation:
No erythema ..............................................................................……………….....................……………………….. 0
Very slight erythema (barely perceptible) ..............................................................……………………………… 1
Well-defined erythema ...................................................................……………………....................……………… 2
Moderate to severe erythema (beet redness) to slight eschar formation (injuries in depth) .........……… 3
Severe erythema (beet redness) to eschar formation preventing grading of erythema .................……… 4

Parameter:

SI

Value:

1

Test group / Remarks:

2%

Parameter:

SI

Value:

0.9

Test group / Remarks:

15%

Parameter:

SI

Value:

0.6

Test group / Remarks:

30%

No irritation and no signs of systemic toxicity were observed in any of the animals.

No mortality occurred and no clinical signs of systemic toxicity were observed in the animals of the main study. Body weights and body weight gain of experimental animals remained in the same range as controls over the study period.

All auricular lymph nodes of the animals of the experimental and control groups were considered normal in size.

No macroscopic abnormalities of the surrounding area were noted for any of the animals.

Mean DPM/animal values for the experimental groups treated with test item concentrations 2, 15 and 30% were 899, 780 and 584 DPM, respectively. The mean DPM/animal value for the vehicle control group was 911 DPM. The SI values calculated for the item concentrations 2, 15 and 30% were 1.0, 0.9 and 0.6, respectively.

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information

Conclusions:

Dilithium adipate would not be regarded as a skin sensitizer.

Executive summary:

This study is carried out in accordance to OECD guideline 429, EU method B.42 and is GLP compliant. Therefore, it is given reliability rating of 1 (reliable without restrictions). Dilithium adipate would not be regarded as a skin sensitizer.

Reference 2

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study is carried out in accordance to OECD guideline 429, EU method B.42 and is GLP compliant. Therefore, it is given reliability rating of 1 (reliable without restrictions).

Justification for type of information:

REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'.

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

Guideline:

EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)

GLP compliance:

yes (incl. QA statement)

Type of study:

other: Local Lymph Node Assay

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: Approximately 10 weeks old
- Weight at study initiation: Body weight variation was within +/- 20% of the sex mean.
- Housing: Makrolon cages containing sterilised sawdust
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24
- Humidity (%): 40-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:

acetone/olive oil (4:1 v/v)

Concentration:

2, 15 and 30 % test item w/w

No. of animals per dose:

5

Details on study design:

RANGE FINDING TESTS: 15 and 30 % test item w/w using 2 animals per concentration

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 days
- Test groups: 5 animals exposed to each concentration
- Control group: 5 animals exposed to the vehicle
- Site: dorsal surface of both ears
- Frequency of applications: Days 1, 2, 3
- Duration: 6 days
- Concentrations: 2, 15 and 30 % test item w/w

SCORE:
Erythema and eschar formation:
No erythema ..............................................................................……………….....................……………………….. 0
Very slight erythema (barely perceptible) ..............................................................……………………………… 1
Well-defined erythema ...................................................................……………………....................……………… 2
Moderate to severe erythema (beet redness) to slight eschar formation (injuries in depth) .........……… 3
Severe erythema (beet redness) to eschar formation preventing grading of erythema .................……… 4

Parameter:

SI

Value:

1

Test group / Remarks:

2%

Parameter:

SI

Value:

0.9

Test group / Remarks:

15%

Parameter:

SI

Value:

0.5

Test group / Remarks:

30%

No irritation and no signs of systemic toxicity were observed in any of the animals.

No mortality occurred and no clinical signs of systemic toxicity were observed in the animals of the main study. Body weights and body weight gain of experimental animals remained in the same range as controls over the study period.

All auricular lymph nodes of the animals of the experimental and control groups were considered normal in size.

No macroscopic abnormalities of the surrounding area were noted for any of the animals.

Mean DPM/animal values for the experimental groups treated with test item concentrations 2, 15 and 30% were 899, 780 and 584 DPM, respectively. The mean DPM/animal value for the vehicle control group was 911 DPM. The SI values calculated for the item concentrations 2, 15 and 30% were 1.0, 0.9 and 0.6, respectively.

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information

Conclusions:

Dilithium adipate would not be regarded as a skin sensitizer.

Executive summary:

This study is carried out in accordance to OECD guideline 429, EU method B.42 and is GLP compliant. Therefore, it is given reliability rating of 1 (reliable without restrictions). Dilithium adipate would not be regarded as a skin sensitizer.

Reference 3

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Between 08 March 2010 and 24 March 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.

Justification for type of information:

REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'.

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

according to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Date of inspection: 15th September 2009 Date of signature: 26th November 2009

Type of study:

mouse local lymph node assay (LLNA)

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories UK Limited, Bicester, Oxon, UK.
- Age at study initiation: eight to twelve weeks old.
- Weight at study initiation: 15 to 23 g
- Housing: individually housed in suspended solid floor polypropylene cages furnished with softwood woodflakes.
- Diet: ad libitum access to food (2014 Teklad Global Rodent diet supplied by Harlan Teklad, Blackthorn, Bicester, Oxon, UK)
- Water: ad libitum access to mains tap water
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Air changes (per hr): approximately fifteen changes per hour
- Photoperiod (hrs dark / hrs light): lighting was controlled by a time switch to give twelve hours continuous light (06.00 to 18.00) and twelve hours darkness.

IN-LIFE DATES: From: Day 0 To: day of sacrifice - Day 6

Vehicle:

dimethylformamide

Concentration:

Preliminary screening test: 50% w/w in dimethyl formamide

Main test: 50, 25 and 10% w/w in dimethylformamide

No. of animals per dose:

Preliminary screening test: one mouse

Main test: four animals in total

Details on study design:

RANGE FINDING TESTS:
- Compound solubility: For the purpose of the study, the test material was freshly prepared as a solution in dimethyl formamide. This vehicle was chosen as it produced the highest concentration that was suitable for dosing.

- Irritation: All animals were observed twice daily on Days 1, 2 and 3 and on a daily basis on Days 4, 5 and 6. Any signs of toxicity or signs of ill health during the test were recorded.

- Lymph node proliferation response: not recorded for preliminary screening test

MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: local lymph node assay
- Criteria used to consider a positive response: The proliferation response of lymph node cells was expressed as the number of radioactive disintegrations per minute per lymph node (disintegrations per minute/node) and as the ratio of 3HTdR incorporation into lymph node cells of test nodes relative to that recorded for the control nodes (Stimulation Index).
The test material will be regarded as a sensitiser if at least one concentration of the test material results in a threefold or greater increase in 3HTdR incorporation compared to control values. Any test material failing to produce a threefold or greater increase in 3HTdR incorporation will be classified as a "non sensitiser".


TREATMENT PREPARATION AND ADMINISTRATION:

Preparation of Test Material
For the purpose of the study, the test material was freshly prepared as a solution in dimethyl formamide. This vehicle was chosen as it produced the highest concentration that was suitable for dosing. The concentrations used are given in the procedure section.

The test material was formulated within two hours of being applied to the test system. It is assumed that the formulation was stable for this duration.
No analysis was conducted to determine the homogeneity, concentration or stability of the test material formulation. This is an exception with regard to GLP and has been reflected in the GLP compliance statement.

Test material administration
Groups of four mice were treated with the test material at concentrations of 50%, 25% or 10% w/w in dimethyl formamide. The preliminary screening test suggested that the test material would not produce systemic toxicity or excessive local irritation at the highest suitable concentration. The mice were treated by daily application of 25 µl of the appropriate concentration of the test material to the dorsal surface of each ear for three consecutive days (Days 1, 2, 3). The test material formulation was administered using an automatic micropipette and spread over the dorsal surface of the ear using the tip of the pipette.
A further group of four mice received the vehicle alone in the same manner.

Positive control substance(s):

hexyl cinnamic aldehyde (CAS No 101-86-0)

Statistics:

None provided

Positive control results:

The Stimulation Index expressed as the mean radioactive incorporation for the treatment group divided by the mean radioactive incorporation of the vehicle control group is as follows:
Concentration (% v/v) in dimethyl formamide
Stimulation Index Result
15 5.16 Positive

Conclusion. α-Hexylcinnamaldehyde, tech., 85% was considered to be a sensitiser under the conditions of the test.

Parameter:

SI

Value:

1.42

Test group / Remarks:

Concentration (%w/w) in dimethyl formamide: 10%

Remarks on result:

other: Negative

Parameter:

SI

Value:

1.77

Test group / Remarks:

Concentration (%w/w) in dimethyl formamide: 25%

Remarks on result:

other: Negative

Parameter:

SI

Value:

2.35

Test group / Remarks:

Concentration (%w/w) in dimethyl formamide: 50%

Remarks on result:

other: Negative

Parameter:

other: disintegrations per minute (DPM)

Value:

3 985

Test group / Remarks:

Concentration (%w/w) in dimethyl formamide: 10%

Remarks on result:

other: see Remark

Remarks:

Disintergrations per minute

Parameter:

other: disintegrations per minute (DPM)

Value:

5 660.72

Test group / Remarks:

Concentration (%w/w) in dimethyl formamide: 25%

Remarks on result:

other: see 'Remark'

Remarks:

Disintergrations per minute

Parameter:

other: Disintergrations per minute (DPM)

Value:

7 038.21

Test group / Remarks:

Concentration (%w/w) in dimethyl formamide: 50%

Remarks on result:

other: see 'Remark'

Remarks:

Disintergrations per minute

There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the test.

Bodyweight changes of the test animals between Day 1 and Day 6 were comparable to those observed in the corresponding control group animals over the same period.

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

The test material was considered to be a non-sensitiser under the conditions of the test.

Executive summary:

Introduction. A study was performed to assess the skin sensitisation potential of the test material in the CBA/Ca strain mouse following topical application to the dorsal surface of the ear. The method was designed to meet the requirements of the following:

§        OECD Guideline for the Testing of Chemicals No. 429 "Skin Sensitisation: Local Lymph Node Assay" (adopted 24 April 2002)

§        Method B42 Skin Sensitisation (Local Lymph Node Assay) of CommissionRegulation (EC) No. 440/2008

Methods. Following a preliminary screening test in which no clinical signs of toxicity were noted at a concentration of50% w/w, this concentration was selected as the highest dose investigated in the main test of the Local Lymph Node Assay. Three groups, each of four animals, were treated with 50 µl (25 µl per ear) of the test material as asolutionindimethyl formamideat concentrations of50%,25% or10% w/w. A further group of four animals was treated withdimethyl formamidealone.

Results. The Stimulation Index expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group are as follows:

Concentration (%w/w) in dimethyl formamide	Stimulation Index	Result
10	1.42	Negative
25	1.77	Negative
50	2.35	Negative

Conclusion. The test material was considered to be a non-sensitiserunder the conditions of the test.

Reference 4

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

Between 08 March 2010 and 24 March 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.

Justification for type of information:

REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'.

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Date of inspection: 15th September 2009 Date of signature: 26th November 2009

Type of study:

mouse local lymph node assay (LLNA)

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories UK Limited, Bicester, Oxon, UK.
- Age at study initiation: eight to twelve weeks old.
- Weight at study initiation: 15 to 23 g
- Housing: individually housed in suspended solid floor polypropylene cages furnished with softwood woodflakes.
- Diet: ad libitum access to food (2014 Teklad Global Rodent diet supplied by Harlan Teklad, Blackthorn, Bicester, Oxon, UK)
- Water: ad libitum access to mains tap water
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Air changes (per hr): approximately fifteen changes per hour
- Photoperiod (hrs dark / hrs light): lighting was controlled by a time switch to give twelve hours continuous light (06.00 to 18.00) and twelve hours darkness.

IN-LIFE DATES: From: Day 0 To: day of sacrifice - Day 6

Vehicle:

dimethylformamide

Concentration:

Preliminary screening test: 50% w/w in dimethyl formamide

Main test: 50, 25 and 10% w/w in dimethylformamide

No. of animals per dose:

Preliminary screening test: one mouse

Main test: four animals in total

Details on study design:

RANGE FINDING TESTS:
- Compound solubility: For the purpose of the study, the test material was freshly prepared as a solution in dimethyl formamide. This vehicle was chosen as it produced the highest concentration that was suitable for dosing.

- Irritation: All animals were observed twice daily on Days 1, 2 and 3 and on a daily basis on Days 4, 5 and 6. Any signs of toxicity or signs of ill health during the test were recorded.

- Lymph node proliferation response: not recorded for preliminary screening test

MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: local lymph node assay
- Criteria used to consider a positive response: The proliferation response of lymph node cells was expressed as the number of radioactive disintegrations per minute per lymph node (disintegrations per minute/node) and as the ratio of 3HTdR incorporation into lymph node cells of test nodes relative to that recorded for the control nodes (Stimulation Index).
The test material will be regarded as a sensitiser if at least one concentration of the test material results in a threefold or greater increase in 3HTdR incorporation compared to control values. Any test material failing to produce a threefold or greater increase in 3HTdR incorporation will be classified as a "non sensitiser".


TREATMENT PREPARATION AND ADMINISTRATION:

Preparation of Test Material
For the purpose of the study, the test material was freshly prepared as a solution in dimethyl formamide. This vehicle was chosen as it produced the highest concentration that was suitable for dosing. The concentrations used are given in the procedure section.

The test material was formulated within two hours of being applied to the test system. It is assumed that the formulation was stable for this duration.
No analysis was conducted to determine the homogeneity, concentration or stability of the test material formulation. This is an exception with regard to GLP and has been reflected in the GLP compliance statement.

Test material administration
Groups of four mice were treated with the test material at concentrations of 50%, 25% or 10% w/w in dimethyl formamide. The preliminary screening test suggested that the test material would not produce systemic toxicity or excessive local irritation at the highest suitable concentration. The mice were treated by daily application of 25 µl of the appropriate concentration of the test material to the dorsal surface of each ear for three consecutive days (Days 1, 2, 3). The test material formulation was administered using an automatic micropipette and spread over the dorsal surface of the ear using the tip of the pipette.
A further group of four mice received the vehicle alone in the same manner.

Positive control substance(s):

hexyl cinnamic aldehyde (CAS No 101-86-0)

Statistics:

None provided

Positive control results:

The Stimulation Index expressed as the mean radioactive incorporation for the treatment group divided by the mean radioactive incorporation of the vehicle control group is as follows:
Concentration (% v/v) in dimethyl formamide
Stimulation Index Result
15 5.16 Positive

Conclusion. α-Hexylcinnamaldehyde, tech., 85% was considered to be a sensitiser under the conditions of the test.

Parameter:

SI

Value:

1.42

Test group / Remarks:

Concentration (%w/w) in dimethyl formamide: 10%

Remarks on result:

other: Negative

Parameter:

SI

Value:

1.77

Test group / Remarks:

Concentration (%w/w) in dimethyl formamide: 25%

Remarks on result:

other: Negative

Parameter:

SI

Value:

2.35

Test group / Remarks:

Concentration (%w/w) in dimethyl formamide: 50%

Remarks on result:

other: Negative

Parameter:

other: disintegrations per minute (DPM)

Value:

3 985

Test group / Remarks:

Concentration (%w/w) in dimethyl formamide: 10%

Remarks on result:

other: see Remark

Remarks:

Disintergrations per minute

Parameter:

other: Disintergrations per minute (DPM)

Value:

5 660.72

Test group / Remarks:

Concentration (%w/w) in dimethyl formamide: 25%

Remarks on result:

other: see ' Remark'

Remarks:

Disintergrations per minute

Parameter:

other: Disintergrations per minute (DPM)

Value:

7 038.21

Test group / Remarks:

Concentration (%w/w) in dimethyl formamide: 50%

Remarks on result:

other: see 'Remark'

Remarks:

Disintergrations per minute

There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the test.

Bodyweight changes of the test animals between Day 1 and Day 6 were comparable to those observed in the corresponding control group animals over the same period.

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

The test material was considered to be a non-sensitiser under the conditions of the test.

Executive summary:

Introduction. A study was performed to assess the skin sensitisation potential of the test material in the CBA/Ca strain mouse following topical application to the dorsal surface of the ear. The method was designed to meet the requirements of the following:

§        OECD Guideline for the Testing of Chemicals No. 429 "Skin Sensitisation: Local Lymph Node Assay" (adopted 24 April 2002)

§        Method B42 Skin Sensitisation (Local Lymph Node Assay) of CommissionRegulation (EC) No. 440/2008

Methods. Following a preliminary screening test in which no clinical signs of toxicity were noted at a concentration of50% w/w, this concentration was selected as the highest dose investigated in the main test of the Local Lymph Node Assay. Three groups, each of four animals, were treated with 50 µl (25 µl per ear) of the test material as asolutionindimethyl formamideat concentrations of50%,25% or10% w/w. A further group of four animals was treated withdimethyl formamidealone.

Results. The Stimulation Index expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group are as follows:

Concentration (%w/w) in dimethyl formamide	Stimulation Index	Result
10	1.42	Negative
25	1.77	Negative
50	2.35	Negative

Conclusion. The test material was considered to be a non-sensitiserunder the conditions of the test.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

No data on skin sensitisation is available for the substance fatty acids lanolin lithium salts. Read across from dilithium adipate and fatty acids lanolin is used to complete the endpoint.

Both dilithium adipate and fatty acids, lanolin are considered not sensitising. The skin sensitisation study was conducted with dilithium adipate (C6) and read across to dilithium sebacate (C10). Testing was undertaken on dilithium adipate as a worst case scenario as this substance is the substance with the shortest chain length, and therefore highest proportion of lithium, in the lithium salts of dicarboxylic acids C6-10 category, which covered the registrations of dilithium adipate (EC 242-449-7), dilithium azelate (EC 254-184-4) and dilithium sebacate.

The skin sensitisation potential of fatty acids, lanolin was tested in a study according to OECD 429 guideline and the test material was considered to be a non-sensitiser under the conditions of the test.

Both studies are GLP-compliant, guideline studies, and have been assigned a Klimisch score of 1. Therefore, the data are considered to be reliable and adequate source studies.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Negative results were produced in the studies with two read across substances, dilithium adipate and fatty acids lanolin.

Therefore, no classification is considered relevant for this endpoint for substance fatty acids lanolin lithium salts.