Registration Dossier

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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
no analytical purity reported

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
adopted in 1992
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
A non-LLNA test is available that was performed prior to the current data requirements, stipulated in Regulation (EC) No 1907/2006. In accordance with the same Regulation, the data was included to avoid unnecessary testing.

Test material

Constituent 1
Reference substance name:
Fatty acids, C5-9, tetraesters with pentaerythritol
EC Number:
267-022-2
EC Name:
Fatty acids, C5-9, tetraesters with pentaerythritol
Cas Number:
67762-53-2
IUPAC Name:
67762-53-2

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Albino Guinea Pigs
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Convance Research Products Inc., Denver, Pennsylvania; USA
- Age at study initiation: approximately 4 - 7 weeks at dosing (range-finding study; intradermal); approximately 9 - 12 weeks (rang-finding study; topical); approximately 5 - 7 weeks at first dose (sensitisation study)
- Weight at study initiation: 376 - 428 g
- Housing: individually housed in suspended, stainless steel cages with wire mesh bottoms
- Diet: certified Guinea Pig Diet, No. 5026, ad libitum
- Water: automatic watering system (Municipal water supply), ad libitum
- Acclimation period: 8 days (range-finding animals); 14 days (sensitisation animals)

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
propylene glycol
Concentration / amount:
Induction: 5% (intradermal), 100% (epicutaneous)
Challenge: 100% and 50%
Challenge
Route:
epicutaneous, occlusive
Vehicle:
propylene glycol
Concentration / amount:
Induction: 5% (intradermal), 100% (epicutaneous)
Challenge: 100% and 50%
No. of animals per dose:
5 (controls), 10 (test groups)
Details on study design:
RANGE FINDING TESTS:
Intradermal: Two animals were administered intradermal injections (2 injections/ animal) of a 5% v/v concentration of test substance in propylene glycol, one on either side of the spinal column. The concentration tested did not produce extensive tissue damage or severe systemic toxicity.

Topical: 4 animals were tested at 4 different concentrations (25, 50, 75% v/v; 100%) per animal (one concentration/site), two on either side of the spinal column. 24 h and 48 h after removal of the patches no signs of erythema and edema were observed for at any of the concentration tested.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal)
- Test group:
Intradermal (3 pairs of injections)
Injection 1: a 1:1 mixture (v/v) FCA/water
Injection 2: test substance in propylene glycol
Injection 3: test substance in a 1:1 mixture (v/v) FCA/water
Epicutaneous: test substance in propylene glycol

- Control group:
Intradermal (3 pairs of injections)
Injection 1: a 1:1 mixture (v/v) FCA/ water
Injection 2: propylene glycol
Injection 3: propylene glycol at 50% (v/v) in a 1:1 mixture (v/v) FCA/water
Epicutaneous: propylene glycol

- Site: shoulder region (intradermal + epicutaneous)
- Frequency of applications: every 7 days
- Duration: Days 1 - 8
- Concentrations: Intradermal 5%, epicutaneous 100%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 22
- Exposure period: 24 h
- Test groups: test substance
- Control group: test substance
- Site: both flanks (two concentrations were applied for a total of two sites per animal)
- Concentrations: 100% and 50%
- Evaluation (hr after challenge): 24 and 48 h after patch removal



Positive control substance(s):
yes
Remarks:
hexylcinnamic aldehyde (HCA)

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
one animal was sacrificed on Day 10 at the end of topical induction exposure, due to dosing trauma (human reasons).
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
one animal was sacrificed on Day 10 at the end of topical induction exposure, due to dosing trauma (human reasons)
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
one animal was sacrificed on Day 10 at the end of topical induction exposure, due to dosing trauma (humane reasons)
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
one animal was sacrificed on Day 10 at the end of topical induction exposure, due to dosing trauma (human reasons)
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
100%
No. with + reactions:
5
Total no. in group:
9
Clinical observations:
1 animal was found dead (not included in total number of 9); edema observed in 3/9 animals; negative control: no positive reactions (10 animals) observed
Remarks on result:
other: separately tested
Remarks:
; positive reactions: if animals exhibited a dermal score of 1 or greater
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
100%
No. with + reactions:
1
Total no. in group:
9
Clinical observations:
1 animal was found dead (not included in total number of 9); no clinical signs observed in any animal; negative control: no positive reactions (10 animals) observed
Remarks on result:
other: separately tested; positive reactions: if animals exhibited a dermal score of 1 or greater

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
CLP: not classified