Amides, 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:

read-across based on grouping of substances (category approach)

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:

guideline study with acceptable restrictions

Justification for type of information:

See section 13 of IUCLID dataset for the read-across justification

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 conducted in 1990 before the requirement for LLNA was published in the regulation. See below for further justification:
Guinea pigs: animal of choice for predictive sensitisation tests

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

Key result

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:

no indication of skin sensitisation

Key result

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:

no indication of skin sensitisation

Key result

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:

no indication of skin sensitisation

Key result

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:

no indication of skin sensitisation

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

positive control

Remarks on result:

not measured/tested

For detailed results tables kindly refer to the attached background materials section of the IUCLID.

Interpretation of results:

GHS criteria not met

Conclusions:

Under the study conditions of the guinea-pig maximisation study, the test substance was considered to be non-sensitising.

Executive summary:

A study was conducted to evaluate the skin sensitisation potential of the read-across substance, C16-18 and C18-unsatd. DEA, according to OECD Guideline 406. A 4 x 6 cm2 area was shaved on the shoulders of the test animals. Two to three hours 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 skin 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. At 24 and 48 h after removal of the adhesive bandage, the reaction was scored. No effects were noted. Under the study conditions of the guinea-pig maximisation study, the test substance was considered to be non-sensitising (Mürmann, 1990).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

A study was conducted to evaluate the skin sensitisation potential of the read across substance, C16-18 and C18-unsatd. DEA, according to OECD Guideline 406. A 4 x 6 cm2 area was shaved on the shoulders of the test animals. Two to three hours 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 skin 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. At 24 and 48 h after removal of the adhesive bandage, the reaction was scored. No effects were noted. Under the study conditions of the guinea-pig maximisation study, the test substance was considered to be non-sensitising (Mürmann, 1990).

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

The read across substance, C16 -18 and C18-unsatd. DEA, was negative in in vivo skin sensitisation testing, therefore no classification is required for this endpoint according to CLP (EC 1272/2008) criteria.