Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

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