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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
key study
Study period:
21 May - 27 July 2002
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
only 5 instead of 10 animals in the test group

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
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 were included to avoid unnecessary testing.

Test material

Constituent 1
Chemical structure
Reference substance name:
Isooctadecanoic acid, ester with oxybis[propanediol]
EC Number:
277-361-8
EC Name:
Isooctadecanoic acid, ester with oxybis[propanediol]
Cas Number:
73296-86-3
Molecular formula:
C24H50O7
IUPAC Name:
16-methylheptadecanoic acid; 3-(2,3-dihydroxypropoxy)propane-1,2-diol
Test material form:
liquid

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Remarks:
Aai: (HA) Outbred
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: not specified
- Microbiological status of animals, when known: viral antibody free
- Age at study initiation: 4 - 6 weeks
- Weight at study initiation: 360 - 450 g
- Housing: stainless steel cages, not further specified
- Diet: Lab Diet Certified Guinea Pig Diet #5026, ad libitum
- Water: tap water, ad libitum
- Acclimation period: min. 7 days
- Indication of any skin lesions: animals were carefully checked prior to test initiation for respiratory or intestinal disease, skin eruptions, mucosal membrane irritation, postural difficulties and general condition

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15.6 - 29.4
- Humidity (%): 30 - 70
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12 / 12

- IN-LIFE DATES: 22 May - 22 June 2002

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: TiterMax/distilled water (1:1)
Concentration / amount:
100% and 5%
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100%
Adequacy of induction:
non-irritant substance, but skin pre-treated with 10% SDS
Challenge
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100%
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
screening study with test group: 3 male, 2 females
test group: 3 males, 2 females
negative control group for test item: 2 males, 3 females
screening study with positive control group: 2 males, 3 females
positive control group: 3 males, 2 females
negative control group for positive control item: 2 males, 3 females
Details on study design:
RANGE FINDING TESTS:
A. INTRADERMAL SCREEN:
It was determined if the test item, injected intradermally, causes local necrosis or ulceration or any systemic toxicity. Skin corrosion potential was screened using 1 guinea pig. 3 injections of 0.1 mL volume were made.

injection 1: 5% in a 50/50 emulsion of TiterMax and distilled water
injection 2: 100%
injection 3: 50% in distilled water

No necrosis or ulceration was noted at 24 and/or 48 h after the injections.

B. TOPICAL SCREEN:
The highest non-irritating concentration (HNIC) for a topical application of the test item was also determined. The test item was diluted in distilled water. 4 animals (2 males and 2 femals) were prepared by close-clipping the dorsal area of their trunks. During all shaving procedures, care was taken to avoid abrading the shaved skin. On the same day, 4 sites on each animal were treated with the test item at decreasing concentrations: 100%, 50%, 25% and 10%. 0.4 mL of the test item were applied to each site. The animals were wrapped after dosing with a piece of 3 inch elastic tape. The wraps remained in place for 24 h before they were removed. Any excess test item was wiped away with ethanol 45 h after application. The test sites were scored 3 h after the ethanol wipe and again 24 h later. The test article elicited no irritation at 100% and therefore that concentration was chosen for the challenge phase.

MAIN STUDY
A. INTRADERMAL INDUCTION EXPOSURE
A 4x6 cm section of the shoulder area of each animal in the test groups was shaved, as detailed previously. 3 pairs of subcutaneous injections (0.1 mL volume) were made in 2 rows; 1 row on each side of the midline. The injection sites were just within the boundaries of the 2x4 cm patch, which was applied 1 week later in the course of the topical induction procedure.

- No. of exposures: 1 (intradermal injection)
- Exposure period: single injection (intradermal)
- Test groups:
Intradermal (3 pairs of injections)
1st pair: TiterMax/water emulsion (1:1), without the test item
2nd pair: 100% test item
3rd pair: 5% test item in TiterMax/distilled water (1:1)
- Control group: not treated
- Site: shoulder region
- Frequency of applications: on first day of induction

B. TOPICAL INDUCTION EXPOSURE
6 days after the injections were made the sites were again shaved. Sodium lauryl sulfate (SLS) at 10% in petrolatum, was then applied to the induction site of each animal to enhance a possible sensitization reaction by provoking a mild inflammatory reaction. 7 days after the injections were made, the test item at 100% was applied to the injection sites. 0.5 mL of the test item was spread onto a 2x4 cm patch of filter paper. The filter paper was placed on the test site and covered with a piece of tape. Further tapes were then wound around the test site of the animal. The wraps and patches were removed after 48 h.

- No. of exposures: 1 (epicutaneous)
- Exposure period: 48 h
- Test groups: 100% test item after treatment with sodium lauryl sulfate (SLS) (10% in petrolatum) to provoke skin irritation
- Control group: not treated
- Site: shoulder region
- Frequency of applications: 7 days after intradermal injection
- Concentrations: 100%

B. CHALLENGE EXPOSURE
2 weeks after the topical induction applications, the challenge application was made. Prior to dosing, a 5x5 cm area of the flank of each guinea pig, in the test group as well as the negative control group was shaved. 0.4 mL of the undiluted (100%) test item was applied to each site. The animals were wrapped after dosing with a piece of 3 inch elastic tape. The wraps remained in place for 24 h. 21 h after unwrapping, any remaining test item was removed with an ethanol wipe and the test site was shaved if necessary. 3 h later, the test site was scored according to the Draize Scale. 24 and 48 h later, the sites were again scored.

- No. of exposures: 1 (epicutaneous)
- Day(s) of challenge: 2 weeks after topical induction exposure
- Exposure period: 24 h
- Test groups: test item only
- Control group: test item only
- Site: flanks
- Concentrations: 100%
- Evaluation (hr after challenge): 24, 48 and 72
Challenge controls:
The control group is actually a challenge control
Positive control substance(s):
yes
Remarks:
1-Chloro-2,4-dinitrobenzene

Results and discussion

Positive control results:
The positive control substance (1-chloro-2,4-dinitrobenzene, induction: 5% in corn oil, challenge: 0.05% in petroleum jelly) induced positive reactions in 4/5 animals (80%) in both the 1st and the 2nd readings after challenge, thus demonstrating the validity of the test.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
Induction: 0%; challenge:100%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
Induction and challenge: 100%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
Induction: 5% in corn oil; challenge: 0.05% in petroleum jelly
No. with + reactions:
4
Total no. in group:
5
Clinical observations:
erythema formation
Remarks on result:
positive indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
Induction: 0%; challenge:100%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
Induction and challenge: 100%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
Induction: 5% in corn oil; challenge: 0.05% in petroleum jelly
No. with + reactions:
4
Total no. in group:
5
Clinical observations:
erythema formation
Remarks on result:
positive indication of skin sensitisation

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.