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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
10 December 2008 - 10 January 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

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:
Study performed according to Japanese regulatory specifications

Test material

Constituent 1
Reference substance name:
Cosmol 13
IUPAC Name:
Cosmol 13
Specific details on test material used for the study:
Lot No. 7-10-A

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Elm Hill Breeding Labs in chelmsford, Massachusetts
- Age at study initiation: 4 - 6 weeks
- Weight at study initiation: 300 - 450 g
- Housing: stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15-29°C
- Humidity (%): 30-70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
other: corn oil and petrolatum
Challenge
Route:
epicutaneous, occlusive
Vehicle:
other: corn oil and petrolatum
No. of animals per dose:
5
Details on study design:
RANGE FINDING TESTS:
Initially, screens were run both intradermally and topically on the test article. It was determined
if five (5) percent of the test article (in a 50/50 emulsion of TiterMax® (TM)2 and distilled water)
injected into the test system, causes local necrosis or ulceration or any systemic toxicity. Onetenth
of one (O.l) milliliter ofthe article/TM/water suspensions was injected, intradermaIly, into
the shaved area between the shoulder blades of one (1) guinea pig, to determine the effect. If
necrosis or ulceration was noted at 24 and/or 48 hours, screening would have continued until a
non-corrosive percentage of the mixture was determined.
The test article alone was similarly screened intradermally to determine a non-corrosive
percentage (100% and 50% in corn oil).
The highest non-irritating concentration (HNIC) for a topical application of the test article was
also determined. Initially the test article was diluted in ethanoP. A group of four (2M:2F)
animals and four (4) concentrations were prepared by close-clipping the dorsal area of their
trunks with an Oster® small animal clipper equipped with a #40 (surgical) head. During all
shaving procedures, care was taken to avoid abrading the skin. On the same day, four (4) sites on
each animal were treated with the test article at decreasing concentrations, suspended or
dissolved in ethanol. Four-tenths (0.4) of a milliliter of the test article was applied to each site
via a 25 mm Hilltop Chamber (with the cotton patch). The animals were wrapped after dosing,
with a piece of three (3) inch Tensoplast® elastic tape (BSN medical S.A.S., Vibraye, France),
that had been split at one (1) end and lined on the adhesive side, opposite the split, with a three
(3) inch wide strip of Hygenic® Dental Dam. The wraps remained in place for 24 hours. After
24 hours, the wraps were removed. Any excess article was wiped away with ethanol at 45 hours
after application. The test sites were scored (see Table 1) three (3) hours after the ethanol wipe
and again 24 hours later. As irritation was observed on all sites, it was decided to rescreen with
petrolatum4 as the diluent. Another group of four (4) animals were prepared, dosed and scored as
indicated above.
Because irritation was observed, the highest non-irritating concentration of the test article (five
(5) percent in petrolatum) was used for the challenge phase ofthe study.

MAIN STUDY
A. INDUCTION EXPOSURE

Five (5) animals each, mixed sex, were used as the test group for both the test article and the
positive control article. Five (5) additional animals were also used as negative control groups for
each article. Only the test groups for the test article and the positive control article underwent the
induction procedures. The negative control groups were not exposed to the articles until the
challenge phase.
The induction phase ofthe test was divided into two (2) stages:
A) Intradermal Injection
A four by six (4 x 6) cm section of the shoulder area of each animal in the test
groups was shaved, as detailed previously:
Three (3) pairs ofintradermal injections were made in two (2) rows; one (1) row on
each side of the midline. The injection sites were just within the boundaries of the
25 mm Hilltop Chamber, which was applied one (1) week later.
1st pair: 0.1 ml TM/water emulsion, without the test or positive eontrol article.
2nd pair: 0.1 ml of eaeh article without TM; test article at the sereen determined
percentage; positive control article at one (1) pereent in eoru oil.
3rd pair: 0.1 ml of eaeh article emulsified in the TM/water emulsion; test article at
the sereen determined percentage; positive control article at one (1) percent.

B) Topical Application
Seven (7) days after the injections were made, the test article was applied at 100%
and the positive control article was applied as a one (l) percent suspension in
petrolatum (an exaggerated dosage). Four-tenths (0.4) of a milliliter of the
appropriate article was applied via a 25 mm Hilltop Chamber (with the cotton
pateh). The animals were wrapped after dosing, with a piece of three (3) inch
Tensoplast® elastic tape, that had been lined on the adhesive side with a three (3)
inch wide strip of dental dam. The wraps and patehes were removed at 48 hours.

B. CHALLENGE EXPOSURE

Two (2) weeks after the topical induction application, the challenge applications were made.
Prior to dosing, a five by five (5 x 5) cm area of the flank of each guinea pig, in the test and
positive control article test groups, as weIl as the negative control groups, were shaved as
detailed previously. The test article at five (5) percent and the positive control article at 0.075,
both in petrolatum, were applied to the flanks ofthe appropriate animals.
Four-tenths (0.4) of a milliliter of each article, at the appropriate concentration, was applied to
each site via a 25 mm Hilltop Chamber (with the cotton patch). The animals were wrapped after
dosing, with a piece ofthree (3) inch Tensoplast® elastic tape, that had been lined on the adhesive
side with a three (3) inch wide strip of dental dam. The wraps remained in place for 24 hours.
Twenty-one ho urs after unwrapping, any remaining article was removed with an ethanol wipe
and the test site was shaved if necessary. Three hours later, the test site was scored according to
the attached Draize Scale (Table 1). Twenty-four and 48 ho urs later, the sites were again scored.
Challenge controls:
0.075% positive control substance in petrolatum
Positive control substance(s):
yes
Remarks:
1-Chloro-2,4-Dinitrobenzene

Results and discussion

Positive control results:
Index: Incidence Severity
Group Test/Control Test/Control
Scoring Interval:
48 Hours: 1.00/0.40 2.40/0.40
72 Hours: 1.00/0.20 1.80/0.20
96 Hours: 0.80/0.00 1.00/0.00









In vivo (non-LLNA)

Resultsopen allclose all
Key result
Hours after challenge:
48
Group:
test chemical
Dose level:
5 % in petrolatum
Total no. in group:
5
Clinical observations:
0/0
Remarks on result:
other: . Hours after challenge: 48.0. Group: test group. Dose level: 5 % in petrolatum. Total no. in groups: 5.0. Clinical observations: 0/0.
Key result
Hours after challenge:
72
Group:
test chemical
Dose level:
5 % in petrolatum
Total no. in group:
5
Clinical observations:
0/0
Remarks on result:
other: . Hours after challenge: 72.0. Group: test group. Dose level: 5 % in petrolatum. Total no. in groups: 5.0. Clinical observations: 0/0.
Key result
Hours after challenge:
96
Group:
test chemical
Dose level:
5 % in petrolatum
Total no. in group:
5
Clinical observations:
0/0
Remarks on result:
other: . Hours after challenge: 96.0. Group: test group. Dose level: 5 % in petrolatum. Total no. in groups: 5.0. Clinical observations: 0/0.
Key result
Hours after challenge:
48
Group:
negative control
Dose level:
5 % in petrolatum
Total no. in group:
5
Clinical observations:
0.4/0.4
Remarks on result:
other: . Hours after challenge: 48.0. Group: negative control. Dose level: 5 % in petrolatum. Total no. in groups: 5.0. Clinical observations: 0.4/0.4.
Key result
Hours after challenge:
72
Group:
negative control
Dose level:
5 % in petrolatum
Total no. in group:
5
Clinical observations:
0/0
Remarks on result:
other: . Hours after challenge: 72.0. Group: negative control. Dose level: 5 % in petrolatum. Total no. in groups: 5.0. Clinical observations: 0/0.
Key result
Hours after challenge:
96
Group:
negative control
Dose level:
5 % in petrolatum
Total no. in group:
5
Clinical observations:
0/0
Remarks on result:
other: . Hours after challenge: 96.0. Group: negative control. Dose level: 5 % in petrolatum. Total no. in groups: 5.0. Clinical observations: 0/0.
Key result
Hours after challenge:
48
Group:
positive control
Dose level:
0.075% in petrolatum
Total no. in group:
5
Clinical observations:
1.0/2.4
Remarks on result:
other: . Hours after challenge: 48.0. Group: positive control. Dose level: 0.075% in petrolatum. Total no. in groups: 5.0. Clinical observations: 1.0/2.4.
Key result
Hours after challenge:
72
Group:
positive control
Dose level:
0.075 % in petrolatum
Total no. in group:
5
Clinical observations:
1.0/1.8
Remarks on result:
other: . Hours after challenge: 72.0. Group: positive control. Dose level: 0.075 % in petrolatum. Total no. in groups: 5.0. Clinical observations: 1.0/1.8.
Key result
Hours after challenge:
96
Group:
positive control
Dose level:
0.075 % in petrolatum
Total no. in group:
5
Clinical observations:
0.8/1.0
Remarks on result:
other: . Hours after challenge: 96.0. Group: positive control. Dose level: 0.075 % in petrolatum. Total no. in groups: 5.0. Clinical observations: 0.8/1.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
This test article, at the concentrations tested, is not a sensitizer in guinea pigs
under the conditions of this test.