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Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15 August 2013 - 23 October 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Presented OECD 406 GPMT study was initially conducted for non-REACH related use for a structural analogue of the registered substance.
In order to avoid further vertebrate animal testing (i.e. conduct a new OECD 429 LLNA) this OECD 406 study is presented within a read across approach (structural analogue; one-to-one read-across).



Test material

Constituent 1
Chemical structure
Reference substance name:
Amides, from diethylenetriamine and hydrogenated tallow
EC Number:
272-926-5
EC Name:
Amides, from diethylenetriamine and hydrogenated tallow
Cas Number:
68920-82-1
Molecular formula:
not applicable
IUPAC Name:
Amides, from diethylenetriamine and hydrogenated tallow
Test material form:
solid: bulk
Details on test material:
Test item without emulsifier was investigated.

Amidoamine 2 (UVCB, based on hydrogenated tallow instead of hydrogenated palm oil):
- Name of test material (as cited in study report): FCM (DETA)M C16-18 TLW hydrogenated (Amidoamine 2 (UVCB) based on hydrogenated tallow instead of hydrogenated palm oil)
- Substance type: Amidoamine
- Chemical name: Amides, from diethylenetriamine and hydrogenated tallow
- CAS 68920-82-1
- Physical state: pale yellowish solid at 20 °C
- Batch No.: PU22340011
- Expiry date of batch: 21 August 2014
- Purity: 100 % (UVCB)
- Storage condition of test material: Room temperature, protected from light
- Stability: stable under test conditions
Specific details on test material used for the study:
Test item without emulsifier was investigated.

Amidoamine 2 (UVCB, based on hydrogenated tallow instead of hydrogenated palm oil):
- Name of test material (as cited in study report): FCM (DETA)M C16-18 TLW hydrogenated (Amidoamine 2 (UVCB) based on hydrogenated tallow instead of hydrogenated palm oil)
- Substance type: Amidoamine
- Chemical name: Amides, from diethylenetriamine and hydrogenated tallow
- CAS 68920-82-1
- Physical state: pale yellowish solid at 20 °C
- Batch No.: PU22340011
- Expiry date of batch: 21 August 2014
- Purity: 100 % (UVCB)
- Storage condition of test material: Room temperature, protected from light
- Stability: stable under test conditions

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male
Details on test animals and environmental conditions:
The animals were kept in pairs in MAKROLON cages at a room temperature of 20°C ± 3°C (maximum range) and a relative humidity of 55% ±
15% (maximum range). Rooms were lit (about 150 lux at approx. 1.50 m room height) on a 12-hour light/12-hour dark cycle.
Tap water (in drinking bottles) was offered ad libitum. Drinking water is examined according to the 'Deutsche Trinkwasserverordnung, 2001'.
Commercial diet, ssniff® Ms-H V2233 (ssniff Spezialdiäten GmbH, 59494 Soest, Germany) served as food. This food was offered ad libitum.

Number of animals: 15
Sex: Male
Age (at start of administration): Approx. 29 days
Body weight (at start of administration): 294 - 337 g
Positive control group: 313 – 371 g
Identification of animals By cage label and coloured marks
Adaptation period At least 5 days

Mortality: daily during the observation period
Clinical signs: daily during the observation period
Body weight: at start of study and at study termination

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: sesame oil
Concentration / amount:
Three pairs of intradermal injections of 0.1 mL were given in the shoulder region which was cleared of hair so that one of each pair lay on each side of midline.

(1) Freund's complete adjuvant (FCA) (diluted 1 : 1 with 0.9% NaCl
(2) the test item (10% in sesame oil)
(3) the test item in a 1+1 mixture (v/v) FCA/physiological saline
Day(s)/duration:
day 0
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
epicutaneous, open
Vehicle:
other: vaseline
Concentration / amount:
0.5 mL sodium laurylsulfate 10% in vaseline
Day(s)/duration:
day 6
Adequacy of induction:
non-irritant substance, but skin pre-treated with 10% SDS
Route:
epicutaneous, occlusive
Vehicle:
other: sesame oil
Concentration / amount:
75% suspension of test item in sesame oil
Day(s)/duration:
day 7 / exposure time: 48 hours
Adequacy of induction:
non-irritant substance, but skin pre-treated with 10% SDS
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: sesame oil
Concentration / amount:
75% suspension of test item in sesame oil
Day(s)/duration:
day 21 / exposure time: 24 hours
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
10 test and 5 control animals were used as a common procedure for animal welfare reason.
Positive control group was carried out non-concurrently with this study during May/June 2013. with 20 animals,
Details on study design:
Induction
The skin reaction results of the first induction exposure were evaluated at 24 and 48 hours, of the second induction at 48 and 72 hours after start of exposure.

Challenge
Days 23 and 24
- 21 hours after removing the filter paper the challenge area was cleaned and cleared of hair if necessary
- three hours later (at 48 hours from the start of challenge application) the skin reaction was observed and recorded
- 24 hours after this observation a second observation (72 hours) was made and recorded.
Positive control substance(s):
yes
Remarks:
α-hexyl cinnamic aldehyde

Results and discussion

Positive control results:
The animals of the positive control group (same origin (strain) as those used in the study) were treated with a 10% (v/v) α-hexyl cinnamic aldehyde solution
intracutaneously in stage 1, undiluted α-hexyl cinnamic aldehyde topically in stage 2 and a 0.01% α-hexyl cinnamic aldehyde solution in stage 3.
In the case of the adjuvant type test method for skin sensitisation detailed OECD 406 guideline or in the case of other adjuvant-type test methods, a response of at least 30% of the animals is considered positive. For the positive control a clear positive reactions 48 and 72 h after challenge were observed (48 h: 100% , 72 h: 65 %). The positive control acceptance criteria were therefore satisfied.

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
2 g of a 75% suspension of the test item in sesame oil/animal
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no visible change (treated skin area)
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
2g sesame oil/animal
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no visible change (treated skin area)
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.01% α-hexyl cinnamic aldehyde solution in sesame oil/animal
No. with + reactions:
20
Total no. in group:
20
Clinical observations:
discrete/patchy erythema or moderate and confluent erythema observed in treated skin area of all animals
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
2 g of a 75% suspension of the test item in sesame oil/animal
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no visible change (treated skin area)
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
2g sesame oil/animal
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no visible change (treated skin area)
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
positive control
Dose level:
0.01% α-hexyl cinnamic aldehyde solution in sesame oil/animal
No. with + reactions:
13
Total no. in group:
20
Clinical observations:
discrete or patchy erythema observed in treated skin area of 13 animals
Remarks on result:
positive indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the present test conditions, the test item revealed no sensitising properties in guinea pigs in a test model according to MAGNUSSON and KLIGMAN.
Executive summary:

In a Klimisch 1 GLP study from Leuschner (2013) the potential of the test item to produce skin sensitisation reactions in guinea pigs in a test model according to the Magnusson and Kligman method was

investigated. Under the present test conditions, the test item revealed no sensitising properties in guinea pigs.

The test item was considered to be non-sensitising to the skin.