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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:
20 Aug - 25 Oct 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
adopted in 1992
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Certifying authority: Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, Erlangen, Germany
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
For the present test substance, the LLNA is not suitable. According to OECD TG 429 certain limitations may justify the use of TG 406 as an alternative, i.e. "false positive findings with certain skin irritants, such as some surfactant type chemicals". As the test substance is a skin irritant surfactant, the GPMT according to OECD test guideline 406 was chosen as the test for skin sensitization.

Test material

Constituent 1
Reference substance name:
Alcohols, C8-10, ethoxylated, sulfates, sodium salts
EC Number:
939-523-2
Cas Number:
1471312-55-6
Molecular formula:
not available
IUPAC Name:
Alcohols, C8-10, ethoxylated, sulfates, sodium salts
Test material form:
semi-solid (amorphous): gel
Remarks:
paste

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Crl: HA (SPF)
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Age at study initiation: Approximately 6 weeks old
- Weight at study initiation: 396 - 492 g
- Housing: Animals were kept in groups in Terluran cages on Altromin saw fibre bedding.
- Diet: Autoclaved hay and Altromin 3122 maintenance diet for guinea pigs; ad libitum
- Water: tap water (drinking water, municipal residue control, microbiological controls at regular intervals); ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 55 +/- 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
2.5% (w/v)
Day(s)/duration:
Study Day 0 three injections
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
epicutaneous, occlusive
Vehicle:
other: vaseline
Concentration / amount:
1.5%
Day(s)/duration:
Study Day 7 Exposure: 48 h
Adequacy of induction:
other: Highest applicable concentration shown to not cause any signs of skin irritation.
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: vaseline
Concentration / amount:
0.5%
Day(s)/duration:
Study Day 20 Exposure: 24 h
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
test group: 10 animals
negative control group: 5 animals
positive control group 5 animals
Details on study design:
RANGE FINDING TESTS:
A range finding test was performed with 10 animals. The concentrations used in the main experiment based on the results of this test.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)
- Test groups:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA/physiological saline 0.9% NaCl
Injection 2: a 2.5% concentration of the test item in physiological saline 0.9% NaCl
Injection 3: a 2.5% concentration of the test item formulated in a 1:1 mixture (v/v) FCA/physiological saline 0.9% NaCl
Epicutaneous: 1.5% in vaseline
- Negative control group:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA/physiological saline 0.9% NaCl
Injection 2: 100% physiological saline 0.9% NaCl
Injection 3: a 50% (v/v) formulation of physiological saline 0.9% NaCl in a 1:1 (v/v) mixture FCA/physiological saline 0.9% NaCl
Epicutaneous: pure vaseline
- Positive control group:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA/physiological saline 0.9% NaCl
Injection 2: 2% mercaptobenzothiazole in cottonseed oil
Injection 3: a 50% (v/v) formulation of 2% mercaptobenzothiazole in a 1:1 (v/v) mixture FCA/physiological saline 0.9% NaCl
Epicutaneous: 25% mercaptobenzothiazole
- Site: shoulder (intradermal + epicutaneous)
- Frequency of applications: Intradermal Day 0, epicutaneous Day 7

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: day 20
- Exposure period: 24 hours
- Test groups: 0.5% of test item in vaseline
- Negative control group: 0.5% of test item in vaseline
- Positive control group: 15% mercaptobenzothiazole
- Site: flank
- Evaluation (hr after challenge): 24 and 48 h after removal of challenge patch.
Positive control substance(s):
yes
Remarks:
mercaptobenzothiazole

Results and discussion

Positive control results:
The positive control substance induced positive reactions in 5/5 animals (100%), thereby validating the test system.

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
induction: 0%; challenge: 0.5%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no effects observed
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
induction: 0%; challenge: 0.5%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no effects observed
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
induction: 2.5%; challenge: 0.5%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no effects observed
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
induction: 2.5%; challenge: 0.5%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no effects observed
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
induction: 2%; challenge: 15%
No. with + reactions:
5
Total no. in group:
5
Clinical observations:
erythema grade 2 in 5/% and oedema grade 1 in 1/5 animals
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
induction: 2%, challenge: 15%
No. with + reactions:
5
Total no. in group:
5
Clinical observations:
erythema grade 2 in 5/5 aniamls
Remarks on result:
positive indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met, no classification required according to Regulation (EC) No 1272/2008.
Conclusions:
Under the present test conditions, the test substance was assessed to have no skin sensitising potential. The test is valid as evidenced by the positive control substance's results. Therefore, the test substance does not meet the classification criteria and no classification is required.