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

Skin sensitisation

Administrative data

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.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Reference substance name:

68425-47-8

Cas Number:

68425-47-8

IUPAC Name:

68425-47-8

Constituent 2

Reference substance name:

Amides, soya, N,N-bis(hydroxyethyl)

EC Number:

270-355-6

EC Name:

Amides, soya, N,N-bis(hydroxyethyl)

IUPAC Name:

270-355-6

Test material form:

other: yellow liquid

Details on test material:

- Name of test material (as cited in study report): Marlamid DF 1818
- Physical state: yellow liquid
- Composition of test material, percentage of components:
80% soybean oil diethanolamide, 10% glycerin, 5% diethanolamine salt of the fatty acids, 3% sodium salt of the fatty acids, 2% free diethanolamine
- Lot/batch No.: 13

In vivo test system

Test animals

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

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal

Vehicle:

corn oil

Induction 2

Concentration / amount:

0.5%

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

corn oil

Challenge 2

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

Results and discussion

Positive control results:

Not reported

In vivo (non-LLNA)

Results

Results 1

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.

Results 2

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.

Results 3

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.

Results 4

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.

Applicant's summary and conclusion

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.