Reaction products of furan-2,5-dione and octadec-1-ene

Endpoint summary

Description of key information

Sensitising

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Reference 1

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2600 (Skin Sensitisation)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

Existing in vivo study was found to have been commissioned by another industry trade group prior to passage of Regulation EU 2016/1688. See Section 8.3.2 of this regulation.

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source:Charles River Laboratories, Research Models and Services, Germany GmbH, Stolzenseeweg 32 – 36, 88353 Kisslegg
- Age at study initiation:5 – 8 weeks
- Weight at study initiation:261 g - 289 g
- Housing:The animals were housed in fully air-conditioned rooms.
- Diet (e.g. ad libitum):ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period:at least 5 days before the first test-item application

ENVIRONMENTAL CONDITIONS
- Temperature (°C):20 – 24°C
- Humidity (%):30 – 70%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 h / 12 h (6.00 a.m. – 6.00 p.m. / 6.00 p.m. – 6.00 a.m.)

Route:

intradermal and epicutaneous

Vehicle:

other: Corn oil (induction), acetone (challenge)

Concentration / amount:

Intradermal Induction:
Test item 5 % in corn oil (w/w)
Test item 5 % in Freund’s complete adjuvant / 0.9% aqueous NaCl-solution (1 : 1)

Epicutaneus Induction:
Test item 25 % in corn oil (w/w)

1ST CHALLENGE
Test item 5 % in acetone (w/w)

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

other: Corn oil (induction), acetone (challenge)

Concentration / amount:

Intradermal Induction:
Test item 5 % in corn oil (w/w)
Test item 5 % in Freund’s complete adjuvant / 0.9% aqueous NaCl-solution (1 : 1)

Epicutaneus Induction:
Test item 25 % in corn oil (w/w)

1ST CHALLENGE
Test item 5 % in acetone (w/w)

No. of animals per dose:

Number of animals per control group: 5 + 1 (spare animal)
Number of animals of the test group: 10 + 1 (spare animal)

Details on study design:

RANGE FINDING TESTS:
1st pretest:
Amount applied: 6 intradermal injections in groups of two per animal were applied to each animal.
A) front row: 2 injections each of 0.1 ml Freund´s complete adjuvant without test item emulsified with 0.9 % aqueous NaCl-solution in a ratio of 1:1
B)middle row: 1 injection of 0.1 ml test item concentration of 50 % and 1 injection of 0.1 ml test item concentration 25 % in corn oil (w/w)
C) 1 injection of 0.1 ml test item concentration of 10 % and 1 injection of 0.1 ml test item concentration 5 % in corn oil (w/w)
Application site: Neck region
Number of test animals: 3 (4 test item concentrations)
Readings: 24 h and 48 h after the beginning of application
4 test item concentrations: 100 % , 75 %, 50 % and 25 % diluted with acetone (w/w) were applied to the left and right flanks of the same animals 7 days later.
Duration of exposure: 24 hours
Readings: 24 h and 48 h after the end of the exposure

2nd pretest:
Amount applied: 6 intradermal injections in groups of two per animal were applied to each animal.
A) front row: 2 injections each of 0.1 ml Freund´s complete adjuvant without test item emusified with 0.9 % aqueous NaCl-solution in a ratio of 1:1
B) middle row: 2 injections each of 0.1 ml test item concentration of 2.5 % in corn oil (w/w)
C) back row: 2 injections each of 0.1 ml test item concentrations of 1 % in corn oil (w/w)
Application site: Neck region
Number of test animals: 3 (2 test item concentrations)
Readings: 24 h and 48 h after the beginning of application

3rd pretest
Amount applied: 0.5 mL of the test-item preparation was applied to each animal
Occlusive dressing: The test patches were fully loaded with the test item, applied to the skin and fixed with a strip of Fixomull stretch.
Occlusion was obtained by covering with teflon foil which was fixed with Guinea Pig Jacket
Duration of exposure: 24 hours
Application site: Flank
Number of test animals: 6 (5 test item concentrations)
Readings: 24 h and 48 h after removal of the patch

MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal induction: 6 intradermal injections in groups of two per animal were given.
Injections for the control group:
A) front row: 2 injections each of 0.1 mL Freund’s complete adjuvant without test item emulsified with 0.9% aqueous NaCl-solution in a ratio of 1 : 1
B) middle row: 2 injections each of 0.1 mL of the undiluted vehicle
C) back row: 2 injections each of 0.1 mL of a 50% formulation of the vehicle without test item emulsified with Freund’s complete adjuvant/ 0.9% aqueous NaCl-solution (1 : 1)
Injections for the test group:
A) front row: 2 injections each of 0.1 mL Freund’s complete adjuvant without test item emulsified with 0.9% aqueous NaCl solution in a ratio of 1 : 1
B) middle row: 2 injections each of 0.1 mL of a test-item preparation in an appropriate vehicle at the selected concentration
C) back row: 2 injections each of 0.1 mL Freund’s complete adjuvant/ 0.9% aqueous NaCl solution (1 : 1) with test item at the selected concentration.
Application site: Neck region
Readings: 24 h after the beginning of application

Epicutaneous induction: Epicutaneous induction was carried out one week after intradermal induction.
Amount applied: 1 mL of the test-item preparation was applied to each animal.
Occlusive dressing: The test patches were fully loaded with the test item, applied to the skin and fixed with a strip of Fixomull stretch
Occlusion was obtained by covering with teflon foil which was fixed with Guinea Pig Jacket
Duration of exposure: 48 hours
Application site: Neck region, same area as in the case of the previous intradermal application
Readings: Directly after removal of the patch
The control group was treated analogously to the test group but only with the vehicle without the test item.


B. CHALLENGE EXPOSURE
The 1st challenge was carried out 14 days after the epicutaneous induction.
Amount applied: 0.5 mL of the test-item preparation was applied to each animal.
The test group and control group were treated with the test-item preparation. Additionally, acetone was applied as a vehicle control.
Occlusive dressing: The test patches were fully loaded with the test item, applied to the skin and fixed with a strip of Fixomull stretch
Occlusion was obtained by covering with teflon foil which was fixed with Guinea Pig Jacket
Duration of exposure: 24 hours
Application site: Flank
test item: right flank posterior
vehicle: left flank posterior
Readings: 24 and 48 h after the removal of the patch

Challenge controls:

A positive control (reliability check) with a known sensitizer is not included in this study. However, a separate study is performed twice a year in the laboratory.
The positive controls with Alpha-Hexylcinnamaldehyde, techn. 85% showed that the test system was able to detect sensitizing compounds under the laboratory conditions chosen.

Positive control substance(s):

yes

Remarks:

Alpha-Hexylcinnamaldehyde

Positive control results:

The sensitivity of Charles River Guinea pigs (Dunkin Hartley, Crl:HA, Charles River Laboratories, Research Models and Services, Germany GmbH, 88353 Kisslegg) and the reliability of experimental techniques was assessed regularly using a known sensitizer as recommended by the test guidelines.
The study procedures were based on the methods of Magnusson and Kligmann (1969) (Maximization Test).

The last check was performed with "HEXYL CINNAMIC ALDEHYDE" (HCA):

Name of Test item: Alpha-Hexylcinnamaldehyde, techn. 85%
CAS number: 101-86-0
Concentrations:
Project No.: TOX139
Intradermal Induction:Test item 2.5% in corn oil, Test item 2.5% in Freund’s complete adjuvant / 0.9%, aqueous NaCl solution (1:1)
Epicutaneous Induction: Test item 100 % (as is)
Challenge: Test item 75 % in acetone
Project No.: TOX144
Intradermal Induction: Test item 2.5% in corn oil, Test item 2.5% in Freund’s complete adjuvant / 0.9% , aqueous NaCl solution (1:1)
Epicutaneous Induction: Test item 100 %
Challenge: Test item 75 % in acetone

Project No.: 151
Intradermal Induction: Test item 2.5% in corn oil, Test item 2.5% in Freund’s complete adjuvant / 0.9%, aqueous NaCl solution (1:1)
Epicutaneous Induction: Test item 100 %
Challenge: Test item 75 % in acetone

All tests indicated a clear skin sensitizing potential of HEXYL CINNAMIC ALDEHYDE (HCA)

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

Test item 5 % in acetone

No. with + reactions:

5

Total no. in group:

10

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: Test item 5 % in acetone . No with. + reactions: 5.0. Total no. in groups: 10.0.

Key result

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

Test item 5 % in acetone

No. with + reactions:

4

Total no. in group:

10

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: Test item 5 % in acetone . No with. + reactions: 4.0. Total no. in groups: 10.0.

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

acetone

No. with + reactions:

0

Total no. in group:

5

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: acetone. No with. + reactions: 0.0. Total no. in groups: 5.0.

Key result

Reading:

2nd reading

Hours after challenge:

48

Group:

negative control

Dose level:

acetone

No. with + reactions:

0

Total no. in group:

5

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: acetone. No with. + reactions: 0.0. Total no. in groups: 5.0.

Interpretation of results:

sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The tested analogue substance, C15-20 ASA, was found to be sensitizing to skin.

Reference 2

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

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

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

This study was conducted on 2,5-furandione, dihydro-, mono-C15- 20-alkenyl derivatives (CAS 68784-12-3), an analogue substance used as the source of information for the assessment of the target substance through read-across. Therefore, this study is informative for evaluation of the environmental fate and toxicity of the target substance, Reaction products of furan-2,5-dione and octadec-1-ene (known here as n-ODSA EC 701-338-8; no CASRN available), and it is adequate for classification and risk assessment.

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2600 (Skin Sensitisation)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

Existing in vivo study was found to have been commissioned by another industry trade group prior to passage of Regulation EU 2016/1688. See Section 8.3.2 of this regulation.

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source:Charles River Laboratories, Research Models and Services, Germany GmbH, Stolzenseeweg 32 – 36, 88353 Kisslegg
- Age at study initiation:5 – 8 weeks
- Weight at study initiation:261 g - 289 g
- Housing:The animals were housed in fully air-conditioned rooms.
- Diet (e.g. ad libitum):ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period:at least 5 days before the first test-item application

ENVIRONMENTAL CONDITIONS
- Temperature (°C):20 – 24°C
- Humidity (%):30 – 70%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 h / 12 h (6.00 a.m. – 6.00 p.m. / 6.00 p.m. – 6.00 a.m.)

Route:

intradermal and epicutaneous

Vehicle:

other: Corn oil (induction), acetone (challenge)

Concentration / amount:

Intradermal Induction:
Test item 5 % in corn oil (w/w)
Test item 5 % in Freund’s complete adjuvant / 0.9% aqueous NaCl-solution (1 : 1)

Epicutaneus Induction:
Test item 25 % in corn oil (w/w)

1ST CHALLENGE
Test item 5 % in acetone (w/w)

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

other: Corn oil (induction), acetone (challenge)

Concentration / amount:

Intradermal Induction:
Test item 5 % in corn oil (w/w)
Test item 5 % in Freund’s complete adjuvant / 0.9% aqueous NaCl-solution (1 : 1)

Epicutaneus Induction:
Test item 25 % in corn oil (w/w)

1ST CHALLENGE
Test item 5 % in acetone (w/w)

No. of animals per dose:

Number of animals per control group: 5 + 1 (spare animal)
Number of animals of the test group: 10 + 1 (spare animal)

Details on study design:

RANGE FINDING TESTS:
1st pretest:
Amount applied: 6 intradermal injections in groups of two per animal were applied to each animal.
A) front row: 2 injections each of 0.1 ml Freund´s complete adjuvant without test item emulsified with 0.9 % aqueous NaCl-solution in a ratio of 1:1
B)middle row: 1 injection of 0.1 ml test item concentration of 50 % and 1 injection of 0.1 ml test item concentration 25 % in corn oil (w/w)
C) 1 injection of 0.1 ml test item concentration of 10 % and 1 injection of 0.1 ml test item concentration 5 % in corn oil (w/w)
Application site: Neck region
Number of test animals: 3 (4 test item concentrations)
Readings: 24 h and 48 h after the beginning of application
4 test item concentrations: 100 % , 75 %, 50 % and 25 % diluted with acetone (w/w) were applied to the left and right flanks of the same animals 7 days later.
Duration of exposure: 24 hours
Readings: 24 h and 48 h after the end of the exposure

2nd pretest:
Amount applied: 6 intradermal injections in groups of two per animal were applied to each animal.
A) front row: 2 injections each of 0.1 ml Freund´s complete adjuvant without test item emusified with 0.9 % aqueous NaCl-solution in a ratio of 1:1
B) middle row: 2 injections each of 0.1 ml test item concentration of 2.5 % in corn oil (w/w)
C) back row: 2 injections each of 0.1 ml test item concentrations of 1 % in corn oil (w/w)
Application site: Neck region
Number of test animals: 3 (2 test item concentrations)
Readings: 24 h and 48 h after the beginning of application

3rd pretest
Amount applied: 0.5 mL of the test-item preparation was applied to each animal
Occlusive dressing: The test patches were fully loaded with the test item, applied to the skin and fixed with a strip of Fixomull stretch.
Occlusion was obtained by covering with teflon foil which was fixed with Guinea Pig Jacket
Duration of exposure: 24 hours
Application site: Flank
Number of test animals: 6 (5 test item concentrations)
Readings: 24 h and 48 h after removal of the patch

MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal induction: 6 intradermal injections in groups of two per animal were given.
Injections for the control group:
A) front row: 2 injections each of 0.1 mL Freund’s complete adjuvant without test item emulsified with 0.9% aqueous NaCl-solution in a ratio of 1 : 1
B) middle row: 2 injections each of 0.1 mL of the undiluted vehicle
C) back row: 2 injections each of 0.1 mL of a 50% formulation of the vehicle without test item emulsified with Freund’s complete adjuvant/ 0.9% aqueous NaCl-solution (1 : 1)
Injections for the test group:
A) front row: 2 injections each of 0.1 mL Freund’s complete adjuvant without test item emulsified with 0.9% aqueous NaCl solution in a ratio of 1 : 1
B) middle row: 2 injections each of 0.1 mL of a test-item preparation in an appropriate vehicle at the selected concentration
C) back row: 2 injections each of 0.1 mL Freund’s complete adjuvant/ 0.9% aqueous NaCl solution (1 : 1) with test item at the selected concentration.
Application site: Neck region
Readings: 24 h after the beginning of application

Epicutaneous induction: Epicutaneous induction was carried out one week after intradermal induction.
Amount applied: 1 mL of the test-item preparation was applied to each animal.
Occlusive dressing: The test patches were fully loaded with the test item, applied to the skin and fixed with a strip of Fixomull stretch
Occlusion was obtained by covering with teflon foil which was fixed with Guinea Pig Jacket
Duration of exposure: 48 hours
Application site: Neck region, same area as in the case of the previous intradermal application
Readings: Directly after removal of the patch
The control group was treated analogously to the test group but only with the vehicle without the test item.


B. CHALLENGE EXPOSURE
The 1st challenge was carried out 14 days after the epicutaneous induction.
Amount applied: 0.5 mL of the test-item preparation was applied to each animal.
The test group and control group were treated with the test-item preparation. Additionally, acetone was applied as a vehicle control.
Occlusive dressing: The test patches were fully loaded with the test item, applied to the skin and fixed with a strip of Fixomull stretch
Occlusion was obtained by covering with teflon foil which was fixed with Guinea Pig Jacket
Duration of exposure: 24 hours
Application site: Flank
test item: right flank posterior
vehicle: left flank posterior
Readings: 24 and 48 h after the removal of the patch

Challenge controls:

A positive control (reliability check) with a known sensitizer is not included in this study. However, a separate study is performed twice a year in the laboratory.
The positive controls with Alpha-Hexylcinnamaldehyde, techn. 85% showed that the test system was able to detect sensitizing compounds under the laboratory conditions chosen.

Positive control substance(s):

yes

Remarks:

Alpha-Hexylcinnamaldehyde

Positive control results:

The sensitivity of Charles River Guinea pigs (Dunkin Hartley, Crl:HA, Charles River Laboratories, Research Models and Services, Germany GmbH, 88353 Kisslegg) and the reliability of experimental techniques was assessed regularly using a known sensitizer as recommended by the test guidelines.
The study procedures were based on the methods of Magnusson and Kligmann (1969) (Maximization Test).

The last check was performed with "HEXYL CINNAMIC ALDEHYDE" (HCA):

Name of Test item: Alpha-Hexylcinnamaldehyde, techn. 85%
CAS number: 101-86-0
Concentrations:
Project No.: TOX139
Intradermal Induction:Test item 2.5% in corn oil, Test item 2.5% in Freund’s complete adjuvant / 0.9%, aqueous NaCl solution (1:1)
Epicutaneous Induction: Test item 100 % (as is)
Challenge: Test item 75 % in acetone
Project No.: TOX144
Intradermal Induction: Test item 2.5% in corn oil, Test item 2.5% in Freund’s complete adjuvant / 0.9% , aqueous NaCl solution (1:1)
Epicutaneous Induction: Test item 100 %
Challenge: Test item 75 % in acetone

Project No.: 151
Intradermal Induction: Test item 2.5% in corn oil, Test item 2.5% in Freund’s complete adjuvant / 0.9%, aqueous NaCl solution (1:1)
Epicutaneous Induction: Test item 100 %
Challenge: Test item 75 % in acetone

All tests indicated a clear skin sensitizing potential of HEXYL CINNAMIC ALDEHYDE (HCA)

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

Test item 5 % in acetone

No. with + reactions:

5

Total no. in group:

10

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: Test item 5 % in acetone . No with. + reactions: 5.0. Total no. in groups: 10.0.

Key result

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

Test item 5 % in acetone

No. with + reactions:

4

Total no. in group:

10

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: Test item 5 % in acetone . No with. + reactions: 4.0. Total no. in groups: 10.0.

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

acetone

No. with + reactions:

0

Total no. in group:

5

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: acetone. No with. + reactions: 0.0. Total no. in groups: 5.0.

Key result

Reading:

2nd reading

Hours after challenge:

48

Group:

negative control

Dose level:

acetone

No. with + reactions:

0

Total no. in group:

5

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: acetone. No with. + reactions: 0.0. Total no. in groups: 5.0.

Due to the presence of a residual raw material, maleic anhydride, at levels above the specific concentration limit for skin sensitisation, the substance is classified for skin sensitisation as Category 1A. See 13th ATP to CLP, Commission Regulation (EU) 2088/1480, Index 607 -096 -00 -9. No data are available

Interpretation of results:

Category 1A (indication of significant skin sensitising potential) based on GHS criteria

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The tested analogue substance, C15-20 ASA, was found to be sensitizing to skin. Based on structural similarity, the registered substance, n-ODSA EC 701-338-8, is also considered a dermal sensitiser. Due to the presence of a residual raw material, maleic anhydride, at levels above the specific concentration limit for skin sensitisation, the substance is classified for skin sensitisation as Category 1A. See 13th ATP to CLP, Commission Regulation (EU) 2088/1480, Index 607 -096 -00 -9.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

An analogue, 2,5-furandione, dihydro-, mono-C15-20-alkenylderivatives (CAS 68784-12-3), was tested in a guinea pig Maximisation Test, and found to be a dermal sensitiser. The target substance, n-ODSA EC 701-338-8, is therefore also considered to be a sensitiser. This is consistent with conclusion of the WHO, 2009, for Cyclic Acid Anhydrides (CICAD 75).

This information is from the substance 2,5-furandione, dihydro-, mono-C15-20-alkenylderivatives (CAS 68784-12-3, a mixture of a hexadecenyl- and octadecenyl succinic anhydrides), an analogue used for the assessment of several endpoints through read-across. The hypothesis for read-across between the substance being registered (Reaction products of furan-2,5-dione and octadec-1-ene; known here as n-ODSA EC 701-338-8; no CASRN available), and the analogue substance is a common functional group: a 2,5-furandione, dihydro- structure, also known as a succinic anhydride, to which is attached a long-chain monounsaturated olefin. In the environment, the anhydride moiety is quickly hydrolysed to form a dioic acid.  When the substance to be registered and the analogue substance are compared, changes in the purity of the starting olefin stock, or small differences in the length (between sixteen and twenty) or arrangement (linear or branched) of the carbon chain are not anticipated to significantly affect the environmental fate properties or the toxicity of the substances. For each endpoint study based upon read-across, the analogue approach is substantiated by an evaluation provided in the Analogue Approach Report Format (AARF) attached to the endpoint study summary file. The AARF allows the read-across information to fulfil the information requirements of the REACH Annexes VII-X, to be the basis for classification and labelling decisions, and for risk assessment.

The registered substance n-ODSA EC 701-338-8, based on the behaviour of a structural analogue (C15 -20 ASA), is classified as a dermal sensitiser according to Regulation EC No. 1272/2008. Due to the presence of a residual raw material, maleic anhydride, at levels above the specific concentration limit for skin sensitisation, the substance is classified for skin sensitisation as Category 1A. See 13th ATP to CLP, Commission Regulation (EU) 2088/1480, Index 607 -096 -00 -9.

Migrated from Short description of key information:
Sensitising to the skin

Justification for selection of skin sensitisation endpoint:
experimental result on a structural analogue

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

The registered substance n-ODSA EC 701-338-8, based on the behaviour of a structural analogue (C15 -20 ASA), is classified as a dermal sensitiser according to Regulation EC No. 1272/2008. Due to the presence of a residual raw material, maleic anhydride, at levels above the specific concentration limit for skin sensitisation, the substance is classified for skin sensitisation as Category 1A. See 13th ATP to CLP, Commission Regulation (EU) 2088/1480, Index 607 -096 -00 -9. No data are available for respiratory sensitisation, although the registered substance is not volatile.