Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
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:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Study available before the requirement for testing using the LLNA method was implemented.
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
Reading:
1st reading
Hours after challenge:
24
Group:
test group
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 group
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:
0%
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: 0%. 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:
0%
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: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
Not applicable
No. with + reactions:
0
Total no. in group:
0
Clinical observations:
Not applicable
Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the guinea-pig maximisation study, the test substance was considered to be non-sensitising.
Executive summary:

A study was conducted to assess the sensitising potential of the test substance in a guinea-pig maximisation test 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 on the 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 2 x 2 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 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 assess the sensitising potential of the read across substance, amides, C16-18 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 the test animals. Two to three hours later, 6 intracutaneous injections were made, simultaneously on the 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 2 x 2 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 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 test substance is not expected to be a skin sensitiser based on a negative in vivo skin sensitisation study conducted on a structurally similar substance. Therefore no classification is required for sensitisation according to CLP (EC 1272/2008) criteria.