Amides, C16-18 and C18-unsatd., N,N-bis(hydroxyethyl)

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Remarks:

GPMT

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From March 19, 1990 to May 2, 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was well conducted according to OECD 406 guideline, but not in compliance with GLP.

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

no

GLP compliance:

no

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

GPMT was already available. See below for further justification:
Guinea pigs: animal of choice for predictive sensitisation tests
Discrimination of potential false-positive/negative results or to confirm previous data
Assessment of delayed contact hypersensitivity

Species:

guinea pig

Strain:

other: Albino Bor:DHPW

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: F. Winkelmann, Borchem, Germany
- Average weight at study initiation: controls: 467 g; test group: 471 g
- Housing: 1 5 animals in macrolon Type IV cages
- Diet (e.g. ad libitum): G4 diet for guinea-pig, Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): Yes
- Acclimation period: 5 - 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1°C
- Humidity (%): 60 +/- 5%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 19-03-1990 To: 12-04-1990

Route:

intradermal

Vehicle:

corn oil

Concentration / amount:

0.5%

Route:

epicutaneous, occlusive

Vehicle:

corn oil

Concentration / amount:

0.5%

No. of animals per dose:

Test group: 20
Controls: 10

Details on study design:

A 4 x 6 cm2 area was shaved on the shoulders of test animals. 2 to 3 h later, 6 intracutaneoius injections were made, simultaneously right and left: 0.1 cm3 of a mix of Freund's Complete Adjuvant (FCA) and water (1+1), 0.1 cm3 of 0.5% test substance in maize oil, 0.1 cm3 of 0.5% test substance in FCA/water (1+1). Controls received 0.1 cm3 of a mix of Freund's Complete Adjuvant (FCA) and water (1+1), 0.1 cm3 maize oil, 0.1 cm3 of FCA/maize oil (1+1).

One week later, a patch test was conducted: a 2 x 4 cm filter paper to which 60% test material in maize oil was applied to freshly shaved skin. The whole was covered with an adhesive bandage for 48 h. Controls received maize oil.

Two weeks later, the right and left flanks were shaved. After 2 - 3 h, a 2x2 cm filter paper with 20% test substance in maize oil was applied for 24 h to the left flank and covered with an adhesive bandage. The same treatment was made on the right flank of each animal with maize oil.

24 and 48 h after removal of the adhesive bandage, the reaction was scored.

Positive control substance(s):

no

Positive control results:

Not reported

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

0.5%

No. with + reactions:

0

Total no. in group:

20

Clinical observations:

None

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

0.5%

No. with + reactions:

0

Total no. in group:

20

Clinical observations:

None

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

maize oil

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

None

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: maize oil. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.

Reading:

2nd reading

Hours after challenge:

48

Group:

negative control

Dose level:

maize oil

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

None

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: maize oil. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the guinea-pig maximisation test, the structurally similar test substance was considered to be non-sensitizing. Hence, it is not considered to be classified as per EU CLP criteria.

Executive summary:

A study was conducted to assess the sensitizing potential of the structurally similar amides, C16-18 (even-numbered) and C18-unsatd., N,N-bis(hydroxyethyl) in a guinea-pig maximisation test according to OECD Guideline 406.

A 4 x 6 cm2 area was shaved on the shoulders of test animals. 2 to 3 h later, 6 intracutaneous injections were made, simultaneously right and left: 0.1 cm3 of a mix of Freund's Complete Adjuvant (FCA) and water (1+1), 0.1 cm3 of 0.5% test substance in maize oil, 0.1 cm3 of 0.5% test substance in FCA/water (1+1). Controls received 0.1 cm3 of a mix of Freund's Complete Adjuvant (FCA) and water (1+1), 0.1 cm3 maize oil, 0.1 cm3 of FCA/maize oil (1+1). One week later, a patch test was conducted: a 2 x 4 cm filter paper to which 60% test substance in maize oil was applied to freshly shaved skin. The whole was covered with an adhesive bandage for 48 h. Controls received maize oil. Two weeks later, the right and left flanks were shaved. After 2 - 3 h, a 2x2 cm filter paper with 20% test substance in maize oil was applied for 24 h to the left flank and covered with an adhesive bandage. The same treatment was made on the right flank of each animal with maize oil. 24 and 48 h after removal of the adhesive bandage, the reaction was scored.

No animals showed any effects to the treatment. Hence, under the conditions of the guinea-pig maximisation test, the test substance was considered to be non-sensitizing. Hence, it is not considered to be classified as per EU CLP criteria.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

A study was conducted to assess the sensitising potential of the amides, C16-18 (even-numbered) and C18-unsatd., N,N-bis(hydroxyethyl) in a guinea-pig maximisation test according to OECD guideline 406.

A 4 x 6 cm²area was shaved on the shoulders of test animals. 2 to 3 hours later, 6 intracutaneous injections were made, simultaneously right and left: 0.1cm³of a mix of Freund's Complete Adjuvant (FCA) and water (1+1), 0.1cm³of 0.5% test substance in maize oil, 0.1cm³of 0.5% test substance in FCA/water (1+1). Controls received 0.1cm³of a mix of Freund's Complete Adjuvant (FCA) and water (1+1), 0.1cm³maize oil, 0.1cm³of FCA/maize oil (1+1). One week later, a patch test was conducted: a 2 x 4 cm filter paper to which 60% test substance in maize oil was applied to freshly shaved skin. The whole was covered with an adhesive bandage for 48 hours. Controls received maize oil. Two weeks later, the right and left flanks were shaved. After 2 - 3 hours, a 2x2 cm filter paper with 20% test substance in maize oil was applied for 24 hours to the left flank and covered with an adhesive bandage. The same treatment was made on the right flank of each animal with maize oil. 24 and 48 hours after removal of the adhesive bandage, the reaction was scored. No effects were noted. Hence, under the conditions of the guinea-pig maximisation test, the test substance was considered to be non-sensitising (Mürmann P, 1990).Therefore no classification is required for sensitisation according to EC criteria (67/548/EEC) and CLP criteria (EC 1272/2008).

Migrated from Short description of key information:

The available in vivo guinea pig maximisation study with amides, C16-18 (even-numbered) and C18-unsatd., N,N-bis(hydroxyethyl) indicates that it is not a skin sensitiser.

Justification for selection of skin sensitisation endpoint:

Only one guideline compliant study was available.

Respiratory sensitisation

Link to relevant study records

Reference

Endpoint:

respiratory sensitisation

Data waiving:

other justification

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

No information could be found on the respiratory sensitisation potential of amides, C16-18 (even-numbered) and C18-unsatd., N,N-bis(hydroxyethyl). DEA-derived fatty acid alkanolamidesin general are not known to be respiratory sensitisers. This substance has low vapour pressure so that normal processing and use conditions will not generate inhalation exposure. In case aerosols or vapours are created under particular conditions (e.g. spraying, elevated temperature/pressure), appropriate risk management measures such as closed systems, exhaust ventilation or wearing of respirators are implemented to control exposure.

Under such conditions, the risk to humans from respiratory sensitisation can be considered minimal and further testing involving vertebrate animals may be omitted, in accordance with Annex XI (1.2) of the REACH regulation.

Migrated from Short description of key information:

No information could be found on the respiratory sensitisation potential of amides, C16-18 (even-numbered) and C18-unsatd., N,N-bis(hydroxyethyl). DEA-derived fatty acid alkanolamides in general are not known to be respiratory sensitisers. This substance has low vapour pressure so that normal processing and use conditions will not generate inhalation exposure. In case aerosols or vapours are created under particular conditions (e.g. spraying, elevated temperature/pressure), appropriate risk management measures such as closed systems, exhaust ventilation or wearing of respirators are implemented to control exposure.

Under such conditions, the risk to humans from respiratory sensitisation can be considered minimal and further testing involving vertebrate animals may be omitted, in accordance with Annex XI (1.2) of the REACH regulation.

Justification for selection of respiratory sensitisation endpoint:

Although no information is currently available, amides, C16-18 (even-numbered) and C18-unsatd., N,N-bis(hydroxyethyl) is not expected to be a respiratory sensitiser based on the available toxicological data.  

Justification for classification or non-classification

Based on the availablein vivoskin sensitisation study, amides, C16-18 (even-numbered) and C18-unsatd., N,N-bis(hydroxyethyl)is not expected to be a skin sensitiser. Therefore no classification is required for sensitisation according to EC criteria (67/548/EEC) and CLP criteria (EC 1272/2008).