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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:
2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: according to EC Directive 92/69/EEC and Regulation EC/440/2008 guideline methods under GLP conditions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
not specified
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
Justification for selection of skin sensitisation endpoint: Two studies available. OECD 429 has not been selected since a LLNA may give fals positive results. See publication of Ball et al., 2011. Regul. Toxicol. Pharmacol. 60:389–400 Study done according to EC Directive 92/69/EEC and Regulation EC/440/2008 guideline methods under GLP conditions. Klimisch rating = 1.

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
473-730-4
EC Name:
-
Cas Number:
928768-73-4
Molecular formula:
C13H28SO3
IUPAC Name:
1-Octanol reaction products with epichlorhydrin and 2-mercaptoethanol
Test material form:
liquid: viscous
Details on test material:
YBY-ASJ-043llU136, Lotlbatch #20074-10142005

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
Animals were received from Elm Hill Breeding Labs, Chelmsford, MA on 0111 1/06, 01/18/06 and 01/25/06.
Following an equilibration period of at least five days, eighteen healthy male and eighteen healthy female
Hartley Albino guinea pigs were randomly assigned to the treatment groups.
The animals were born on 12/21/05, 12/28/05 and 01/08/06. The pretest body weight range was 280 -
391 g for males and 262 - 344 g for females. The weight variation of the animals did not exceed + 20% of
the mean weight. The animals were identified by cage notation and a uniquely numbered metal eartag
and housed llcage in suspended wire mesh cages. Bedding was placed beneath the cages and changed
at least three timeslweek. Fresh PMI Guinea Pig Chow (Diet #5025) and water were available ad libitum.
The animal room, reserved exclusively for guinea pigs on acute tests, was temperature controlled, had a
12 hour lightldark cycle, and was kept clean and vermin free.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
corn oil
Concentration / amount:
The test article was used as received and prepared in corn oil, to the following five concentrations: 1, 10,
25, 50 and 75%. Three guinea pigs were dosed intradermally using a syringe and 23 gauge needle, with
0.1 ml of each of the following test article concentrations: 1, 10, 25 and 50%. Three other guinea pigs
were dosed topically with 0.1 ml of each of the following test article concentrations: 25, 50, 75 and 100%.
For the topical applications, 0.1 ml of the test article mixture was applied to 2 x 2 cm squares of
Whatman's #I filter paper which were applied to the skin. The patches, occluded with plastic and
fastened with non-irritating tape, remained in place for 24 hours.
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
The test article was used as received and prepared in corn oil, to the following five concentrations: 1, 10,
25, 50 and 75%. Three guinea pigs were dosed intradermally using a syringe and 23 gauge needle, with
0.1 ml of each of the following test article concentrations: 1, 10, 25 and 50%. Three other guinea pigs
were dosed topically with 0.1 ml of each of the following test article concentrations: 25, 50, 75 and 100%.
For the topical applications, 0.1 ml of the test article mixture was applied to 2 x 2 cm squares of
Whatman's #I filter paper which were applied to the skin. The patches, occluded with plastic and
fastened with non-irritating tape, remained in place for 24 hours.
Details on study design:
Test Animals
Animals were received from Elm Hill Breeding Labs, Chelmsford, MA on 0111 1/06, 01/18/06 and 01/25/06.
Following an equilibration period of at least five days, eighteen healthy male and eighteen healthy female
Hartley Albino guinea pigs were randomly assigned to the treatment groups.
The animals were born on 12/21/05, 12/28/05 and 01/08/06. The pretest body weight range was 280 -
391 g for males and 262 - 344 g for females. The weight variation of the animals did not exceed + 20% of
the mean weight. The animals were identified by cage notation and a uniquely numbered metal eartag
and housed llcage in suspended wire mesh cages. Bedding was placed beneath the cages and changed
at least three timeslweek. Fresh PMI Guinea Pig Chow (Diet #5025) and water were available ad libitum.
The animal room, reserved exclusively for guinea pigs on acute tests, was temperature controlled, had a
12 hour lightldark cycle, and was kept clean and vermin free.
Site Preparation
The day prior to the screen, lnduction A, lnduction B, or Challenge, the sites (back or sides) were clipped
free of hair with an electric clipper. Upon examination prior to the screen or lnduction A, animals with skin
irregularities or irritation were eliminated from the study.
Preliminary Screen
The preliminary screen was conducted to determine the concentration for intradermal injection which was
not necrotic, ulcerogenic or toxic. For the topical application, the concentration of the test article must be
well tolerated systemically and produce no more than mild to moderate skin irritation. Based on the
results of the preliminary screen, the intradermal concentration selected was 1%, and the topical
concentration was 100%.
The test article was used as received and prepared in corn oil, to the following five concentrations: 1, 10,
25, 50 and 75%. Three guinea pigs were dosed intradermally using a syringe and 23 gauge needle, with
0.1 ml of each of the following test article concentrations: 1, 10, 25 and 50%. Three other guinea pigs
were dosed topically with 0.1 ml of each of the following test article concentrations: 25, 50, 75 and 100%.
For the topical applications, 0.1 ml of the test article mixture was applied to 2 x 2 cm squares of
Whatman's #I filter paper which were applied to the skin. The patches, occluded with plastic and
fastened with non-irritating tape, remained in place for 24 hours.
Sensitization Study
There are two stages to the maximization test. The first stage is the induction and consists of intradermal
injections followed in 7 days by a topical application of the test article. The second stage is the challenge
which consists of a topical application performed 14 days following completion of the induction phase.
Dosing
One group of tenisex served as the test article group. One group of fivelsex served as the control group.
lnduction A: Six intradermal injections, using a 23 gauge needle, were made on the 4 x 6 cm prepared
site as follows:
Sites "b" received 0. 1 ml of a 1 % concentration of the test article mixture on both sjdes or 100% corn
oil on both sides
Sites "c" received 0.1 ml of a mixture containing equal parts of 50% FCA and a 1 % concentration of
the test article on both sides or equal parts of 50% FCA and corn oil on both sides
lnduction 6: Because a 100% concentration of the test article did not produce irritation in the preliminary
screen, the animals were pretreated with 0.5 ml of a 10% mixture of sodium lauryl sulfate approximately
24 hours prior to induction B and the sites remained unoccluded. At least 2 hours prior to lnduction B, any
residual sodium lauryl sulfate solution was removed with distilled water. Seven days after lnduction A, the
guinea pigs in the test article group were dosed topically (at 'IND B', on the chart above) using 2 x 4 cm
patches of Whatman's #I filter paper, saturated with 0.2 ml of the 100% concentration. The patches,
occluded with plastic and fastened with adhesive tape, remained in place for 48 hours. The guinea pigs in
the control group were dosed in the same manner with the vehicle control.
Challenqe: Fourteen days after lnduction B, the test and control animals were challenged topically (at 'test
art.' on the chart above) using 2 x 2 cm patches of Whatman's #1 filter paper, saturated with 0.1 ml of a
50% concentration of the test substance. The vehicle was applied topically (at 'veh' on the chart above).
All sites were occluded with plastic and secured with non-irritating tape for 24 hours
Type and Frequency of Observations
Skin reactions:
Induction A: The treated site of each animal was examined and scored for dermal reactions at 24
and 48 hours after injection.
Induction B: The treated site of each animal was examined and scored at 48 hours after application
of the saturated patch.
Challenge: The challenge sites, both test article and control, of each animal were examined and
scored at 24 and 48 hours after patch removal.
Erythema was evaluated using the following numerical scale. Additional signs were described
No visible change
Discrete or patchy erythema
Moderate and confluent erythema
Intense erythema and swelling
Clinical signs: Animals were observed once daily for mortality and toxicity
Body Weights: Body weights were recorded pretest and at termination.
Sacrifice: At study termination, all survivors were humanely sacrificed using C02.
Analysis of Data
A score of 1 or greater at challenge is considered to be a positive reaction. Sensitization potential is
determined according to the following table:

Sensitization Grade Sensitization Classification
Rate (%)
0-8 I Weak
9-28 II Mild
29-64 Ill Moderate
65-80 IV Strong
81-100 V Extreme

Challenge controls:
Challenge: The challenge sites, both test article and control, of each animal were examined and
scored at 24 and 48 hours after patch removal.
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50 % of Test Substance
No. with + reactions:
2
Total no. in group:
20
Clinical observations:
None
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50 % of Test Substance
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
None
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
25 % 2-Mercaptobenzothiazole
No. with + reactions:
6
Total no. in group:
20
Clinical observations:
None
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
25 % 2-Mercaptobenzothiazole
No. with + reactions:
2
Total no. in group:
20
Clinical observations:
None
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50 % corn oil
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50 % corn oil
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None

Any other information on results incl. tables

Dermal Observations (Post Induction A)
FCA Test Substance Test Substance (TS)
0.1 ml of 50% conc. In destilled water 0.1 ml of 1% conc. Mixture 0.1 ml of equal parts 50% FCA & 1% TS
Site a - Left Site a - Right Site b - Left Site b - Right Site c - Left Site c - Right
Animal# Sex 24 hours 48 hours 24 hours 48 hours 24 hours 48 hours 24 hours 48 hours 24 hours 48 hours 24 hours 48 hours
C9906 M 1 1 1 1 1 1 1 1 1 0 2 1
C9907 M 2 1 2 1 1 1 1 1 0 0 1 1
C9908 M 1 1 1 1 1 0 1 0 1 1 1 1
C9909 M 2 2 2 2 1 1 1 1 2 2 2 2
C9910 M 1 1 1 1 0 0 0 0 1 1 1 1
C9911 M 1 2 1 2 1 1 1 1 1 2 1 2
C9912 M 1 0 0 0 0 0 0 0 1 1 1 1
C9913 M 1 1 1 1 1 0 1 0 1 1 0 1
C9914 M 1 1 1 1 1 0 1 0 0 0 1 1
C9915 M 2 2 2 2 1 1 1 0 1 1 1 1
C9916 F 1 2 1 2 0 0 1 1 0 0 0 0
C9917 F 2 1 2 1 0 0 0 0 0 0 0 0
C9918 F 1 2 1 2 1 1 0 1 1 0 1 1
C9919 F 1 1 1 1 1 0 1 1 1 1 1 1
C9920 F 1 1 1 1 1 1 1 1 1 1 1 1
C9921 F 1 1 1 1 1 1 0 0 1 0 1 1
C9922 F 1 1 1 1 1 1 1 1 2 1 1 1
C9923 F 1 0 1 1 1 0 2 0 2 1 2 0
C9924 F 1 1 1 1 0 0 1 0 1 1 1 1
C9925 F 0 0 0 0 0 1 1 1 1 0 1 1
Vehicle Control; Corm Oil, Dermal Observations (Post Induction A)
FCA Test Substance Test Substance (TS)
0.1 ml of 50% conc. In destilled water 0.1 ml of 1% conc. Mixture 0.1 ml of equal parts 50% FCA & 1% TS
Site a - Left Site a - Right Site b - Left Site b - Right Site c - Left Site c - Right
Animal# Sex 24 hours 48 hours 24 hours 48 hours 24 hours 48 hours 24 hours 48 hours 24 hours 48 hours 24 hours 48 hours
C9926 M 2 1 2 1 1 0 1 0 1 1 0 1
C9927 M 1 1 1 1 1 1 1 1 1 1 1 1
C9928 M 1 1 1 1 0 0 0 1 1 1 1 1
C9929 M 0 1 0 1 0 0 0 0 0 0 0 0
C9930 M 1 0 1 1 1 0 1 0 1 0 2 1
C9931 F 2 1 2 1 0 0 0 0 1 1 1 1
C9932 F 1 0 0 1 1 0 1 0 1 0 1 1
C9933 F 1 1 1 1 0 0 0 0 1 0 1 1
C9934 F 2 1 1 1 0 0 0 0 0 0 1 1
C9935 F 2 1 1 1 0 0 0 0 1 1 0 0
Vehicle Control; Corm Oil, Dermal Observations (Post Induction B)
Induction B (0.2 ml) Challenge (0.1 ml)
100% corn oil Left Flank, 50% conc. of test substance Right Flank, 100% corn oil
Animal# Sex 48 hours 24 hours 48 hours 24 hours 48 hours
C9926 M 2 0 0 0 0
C9927 M 1 0 0 0 0
C9928 M 0 0 0 0 0
C9929 M 3 0 0 0 0
C9930 M 1 0 0 0 0
C9931 F 3 0 0 0 0
C9932 F 1 0 0 0 0
C9933 F 2 0 0 0 0
C9934 F 1 0 0 0 0
C9935 F 0 0 0 0 0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Migrated information
Conclusions:
According to the GHS purple book, at least a 30% response in a guinea pig Maximization Test (OECD 406) is needed to consider a material to be a dermal sensitizer. The test substance is a non-sensitizer since the response was only 10%.
Executive summary:

The test substance is a non-sensitizer since the response was only 10%.