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Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1992-07-21 to 1992-09-10
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study but low animal number.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
(1981)
Deviations:
yes
Remarks:
Only 10 instead of 20 animals treated.
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
Test was done before LLNA as first-choice method for in-vivo testing was set into force.
Species:
guinea pig
Strain:
other: Pirbright white, Bor: DHPW
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS:
- Source: Winkelmann, Borchen, Germany
- Weight at study initiation: Approximately 340 g (main study)
- Age at study initiation: Approximately 6 weeks
- Housing: 2-3 animals per cage in Macrolone cages (type IV)
- Bedding: Softwood bedding, ARWI-Center, Essen, Germany
- Diet: Pelleted Altromin Maintenance Diet 3022, Lage, Lippe, ad libitum
- Water: (tap/filtered) Water, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS:
- Temperature (°C): 20-25
- Humidity (%): 45-70
- Air changes (per hr): at least 8
- Photoperiod (hrs dark / hrs light): 12/12
Route:
epicutaneous, occlusive
Vehicle:
other: 0.9% sodium chloride
Concentration / amount:
PRELIMINARY STUDY:
1, 2, 4, 6, 12.5, 25 and 50%

MAIN STUDY:
- Induction: 4%
- Challenge: 2%
Route:
epicutaneous, occlusive
Vehicle:
other: 0.9% sodium chloride
Concentration / amount:
PRELIMINARY STUDY:
1, 2, 4, 6, 12.5, 25 and 50%

MAIN STUDY:
- Induction: 4%
- Challenge: 2%
No. of animals per dose:
3 (preliminary study), 5 (dose finding for challenge), 10 (controls),10 (test group)
Details on study design:
RANGE FINDING TESTS:
- The concentrations of 1, 2, 4, 6, 12.5, 25 and 50% were applied to determine concentrations of the test substance suitable for induction of sensitization and for sensitization challenge.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Test groups: test substance in 0.9% sodium chloride
- Control group: 0.9% sodium chloride
- Site: left flank
- Frequency of applications: every 7 days
- Duration: days 0-14
- Concentration: 4%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: 28 (14 days after 3rd induction treatment)
- Exposure period: 6 h
- Test groups: test substance in 0.9% sodium chloride
- Control group: 0.9% sodium chloride
- Site: bilateral to sheared flanks (caudal and medial position)
- Concentrations: 2%
- Evaluation: 24 and 48 h after patch removal
Challenge controls:
The control group is actually a challenge control. Animals were challenged on the flank treated during induction and on the other flank as challenge control.
Positive control substance(s):
not specified
Positive control results:
Reliability check was performed in November 1992.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
2%
No. with + reactions:
4
Total no. in group:
10
Clinical observations:
weak dermal effects
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 2%. No with. + reactions: 4.0. Total no. in groups: 10.0. Clinical observations: weak dermal effects .
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
2%
No. with + reactions:
3
Total no. in group:
10
Clinical observations:
weak dermal effects
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 2%. No with. + reactions: 3.0. Total no. in groups: 10.0. Clinical observations: weak dermal effects.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
2%
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
weak dermal effects
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 2%. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: weak dermal effects .
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
2%
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
weak dermal effects
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 2%. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: weak dermal effects .

Table 1: Skin reactions 24 and 48 h after challenge exposure

 

24 h reading

48 h reading

Group

 Control

Treatment (2%)

 Control

Treatment (2%)

Flank*

left

right

left

right

left

right

left

right

None

6/10

7/10

7/10

8/10

9/10

9/10

9/10

9/10

Weak

4/10

3/10

3/10

2/10

1/10

1/10

1/10

1/10

Moderate

0/10

0/10

0/10

0/10

0/10

0/10

0/10

0/10

strong

0/10

0/10

0/10

0/10

0/10

0/10

0/10

0/10

*Left flank was used for induction treatment

(Number of animals with skin reaction/total number of animals)

MORTALITY/BODY WEIGHT:

No mortality occured. There was no significant difference in body weight gain between the treatment and the control group.       

After the third induction treatment, all animals treated with the vehicle did not show any sign of skin irritation. 5 animals treated with the test item showed only weak effects after 1 h, whereas 8 animals showed weak and one animal moderate skin reactions after 24 h.

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

There is one study regarding skin sensitization with C12-14AS MEA (CAS 90583-16-7) available. Additionally a read-across from the structurally related AS C12-14AS Na (CAS 85586-07-8) was performed. The possibility of a read-across to other alkyl sulfates in accordance with Regulation (EC) No 1907/2006 Annex XI 1.5. Grouping of substances and read-across approach was assessed. In Annex XI 1.5 it is given that a read-across approach is possible for substances, whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity. The AS reported within the AS category show structural similarity. The most important common structural feature of the category members is the presence of a predominantly linear aliphatic hydrocarbon chain with a polar sulfate group, neutralized with a counterion. This structural feature confers the surfactant properties of the alkyl sulfates. The surfactant property of the members of the AS category in turn represent the predominant attribute in mediating effects on mammalian health. Therefore, the AS of the AS category have similar physicochemical, environmental and toxicological properties, validating the read-across approach within the category. The approach of grouping different AS for the evaluation of their effects on human health and the environment was also made by the OECD in the SIDS initial assessment profile [1] and by a voluntary industry programme carrying out Human and Environmental Risk Assessments (HERA [2]), further supporting the read across approach between structurally related AS.

There is a substantial data base on the counter ion ethanolamine (MEA) online available. MEA is listed in Annex VI of Regulation 1272/2008. It is classified Acute Tox. 4; H302, H312 and H332 as well as Skin Corr. 1B; H314. Additionally a specific concentration level is established for STOT SE3, H335 at concentrations ≥ 5% in Annex VI of Regulation 1272/2008. The effects of MEA on human health were assessed by the OECD in the SIDS initial assessment Report [3]. As MEA is not classified regarding skin sensitization it is expected that MEA will not confer sensitizing properties.

 

The skin sensitizing potential of C12-14AS MEA (CAS 90583-16-7, analytical purity 30-31%) was assessed in a Buehler Test similar to OECD Guideline 406 (Pittermann, 1993). Concentrations of the main study are based on preliminary range finding studies. 10 female guinea pigs were induced by occluded epicutaneous exposure with 4% test material (based on active ingredient). Another 10 female guinea pigs served as vehicle control. Three induction applications were placed on the same skin area once a week. Results of the third induction were evaluated 1 and 24 h after the end of exposure. Challenge was performed with 2% (based on active ingredient) 14 days after the last induction treatment. All animals were scored for skin reactions 24 and 48 h after challenge. After the third induction treatment, all animals treated with the vehicle did not show any sign of skin irritation. 5 animals treated with the test item showed only weak effects after 1 h, whereas 8 animals showed weak and one animal moderate skin reactions after 24 h. 24 h after challenge, weak dermal effects were observed on three animals of the treatment group and on four animals at the untreated application site. 48 h after challenge one animal showed weak dermal effects on the induction site and the untreated site, respectively. Thus, the test item showed no sensitising potential within this study.

The skin sensitizing potential of C12-14AS Na (CAS 85586-07-8, analytical purity 29.9%) was assessed in a Guinea Pig Maximisation Test similar to OECD Guideline 406 (Unilever, 1977). In this study 10 guinea pigs were induced by intradermal and occlusive epicutaneous application of the test item at concentrations of 0.08% (intradermal induction) and 0.5% (epicutaneous induction). Challenge and re-challenge was performed with 0.1%. Water was used as vehicle. None of the treated animals showed a positive reaction after challenge. Thus, the test item showed no sensitising potential within this study.

Results of the studies show that C12-14AS MEA (CAS 90583-16-7) is not a skin sensitizer. In addition, a structurally related alkyl sulfate, sodium lauryl sulphate (C12AS Na), is recommended as an agent to induce local irritation in an OECD method to assess skin sensitising properties of chemicals (OECD Guideline 406, Guinea Pig Maximisation Test). Therefore, there is a lot of experience with sodium lauryl sulfate in sensitising studies and no evidence that it shows sensitising properties. Thus, skin sensitisation by members of the alkyl sulfates category is generally unlikely.

[1] SIDS initial assessment profile, (2007); http://www.aciscience.org/docs/Alkyl_Sulfates_Final_SIAP.pdf

[2] (HERA Draft report, 2002); http://www.heraproject.com/files/3-HH-04-%20HERA%20AS%20HH%20web%20wd.pdf

[3] SIDS initial assessment report, (2013);

http://webnet.oecd.org/HPV/UI/SIDS_Details.aspx?key=8aefe41b-8499-4052-943f-f6dd6f8c5997&idx=0

 


Migrated from Short description of key information:
Skin sensitisation (GPMT and Buehler - OECD 406): not sensitising

Justification for selection of skin sensitisation endpoint:
Reliable study performed similar to OECD guideline.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The available data on skin sensitisation do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.

No data available for respiratory sensitisation.