Registration Dossier
Registration Dossier
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EC number: 942-322-2 | CAS number: -
Skin sensitisation
Administrative data
- 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.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1993
Materials and methods
Test guideline
- 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.
Test material
- Reference substance name:
- Sulfuric acid, mono-C12-14-alkyl esters, compds. with ethanolamine
- EC Number:
- 292-214-8
- EC Name:
- Sulfuric acid, mono-C12-14-alkyl esters, compds. with ethanolamine
- Cas Number:
- 90583-16-7
- IUPAC Name:
- 90583-16-7
- Details on test material:
- - Name of test material (as cited in study report): Trade Name, sulfuric acid, mono C12-14-alkylesters, compounds with ethanolamine
- Physical state: Liquid
- Content of active substance: 30%
- Lot/batch No.: 17
- Stability under test conditions: 12 months
- Storage condition of test material: Room temperature
- Expiration date: 1993-06-16
Constituent 1
In vivo test system
Test animals
- 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
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- 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%
Challengeopen allclose all
- 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
Results and discussion
- Positive control results:
- Reliability check was performed in November 1992.
In vivo (non-LLNA)
Resultsopen allclose all
- 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 .
Any other information on results incl. tables
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.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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