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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)
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.