Rape oil, reaction products with diethanolamine

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

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

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 on the structural anaolgue amides, C16-18 (even-numbered) and C18-unsatd., N,N-bis(hydroxyethyl).

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

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 according to CLP criteria (EC 1272/2008).

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 treamment. 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 according to CLP criteria (EC 1272/2008).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

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 (Mürmann P, 1990). Hence, it is not considered to be classified according to CLP criteria (EC 1272/2008).

Migrated from Short description of key information:
The available in vivo skin sensitisation study with structurally similar amides, C16-18 (even-numbered) and C18-unsatd., N,N-bis(hydroxyethyl) shows that the test substance is not a skin sensitiser and therefore based on read-across HE Rape Oil, reaction product with diethanolamine is not expected to be a skin sensitiser either.

Justification for selection of skin sensitisation endpoint:
Only one guideline compliant study with structurally similar substance amides, C16-18 (even-numbered) and C18-unsatd., N,N-bis(hydroxyethyl) was available.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

As chemical respiratory sensitisers also elicit positive results in predictive tests for contact sensitisation, a negative outcome for dermal sensitisation is also predictive for non-respiratory sensitisation of the substance. The substance is a liquid with a low vapour pressure. Due to its physical chemical properties, it is unlikely that it will form inhalable dust, mist or fumes when handled and used in solid form. In case inhalable forms of the substance (either pure or in aqueous solutions) 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 following inhalation exposure 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:
As chemical respiratory sensitisers also elicit positive results in predictive tests for contact sensitisation, a negative outcome for dermal sensitisation is also predictive for non-respiratory sensitisation of the substance. The substance is a liquid with a low vapour pressure. Due to its physical chemical properties, it is unlikely that it will form inhalable dust, mist or fumes when handled and used in solid form. In case inhalable forms of the substance (either pure or in aqueous solutions) 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 following inhalation exposure 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, the registered material is not expected to be a respiratory sensitiser based on the available toxicological data.

Justification for classification or non-classification

HE Rape Oil, reaction product with diethanolamine is not expected to be a skin sensitiser based on the available in vivo skin sensitisation study conducted on structurally similar substance. Therefore no classification is required for sensitisation according to EC criteria (67/548/EEC) and CLP criteria (EC 1272/2008).