Registration Dossier
Registration Dossier
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EC number: 701-179-4 | CAS number: -
Toxicological information
Skin sensitisation
Currently viewing:
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1989-10-31 to 1989-12-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline and GLP study, please refer to section 13 for read across justification
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- In 1992 (performance of the available study), the LLNA was not a standard test method.
Test material
- Reference substance name:
- Sodium sulphooctadecanoate
- EC Number:
- 268-062-3
- EC Name:
- Sodium sulphooctadecanoate
- Cas Number:
- 67998-94-1
- Molecular formula:
- C18H36O5S.xNa
- IUPAC Name:
- sodium 2-sulfooctadecanoate
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Fa. Winkelmann, Borchen/D
- Weight at study initiation: 380-390 g, 350-390 g
- Housing: Makrolon cages IV
- Diet: 3032 DK (Altromin GmbH, Lage/D), ad libitum
- Water: Tap water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25 °C
- Humidity (%): 45-70%
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Vaseline and NaCl
- Concentration / amount:
- Pretest: 0.5, 1, 2, 3 %
Main test: Intracutaneous Induction: 0.3 % in NaCl
Epicutaneous Induction: 60 % in Vaseline
Challenge: 40 % in Vaseline and 40 % NaCl
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Vaseline and NaCl
- Concentration / amount:
- Pretest: 0.5, 1, 2, 3 %
Main test: Intracutaneous Induction: 0.3 % in NaCl
Epicutaneous Induction: 60 % in Vaseline
Challenge: 40 % in Vaseline and 40 % NaCl
- No. of animals per dose:
- 36 animals in total
(2x3 in the preliminary test, 20 animals in testing group, 10 animals in control group) - Details on study design:
- RANGE FINDING TESTS: The minimal irritating doses were determined on 3 guinea-pigs. All animals were applied 0.1 mL 50 % Freundsche Adjuvans before the preliminary tests.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intracutaneous and epicutaneous), the epicutaneous injection was done 8 days after the first injection
- Exposure period: 48 hours
- Test groups:
Intracutaneous Application: 20 animals received 0.1 mL of the following solutions: 1. Freudsche Adjuvans, 2. the minimal concentration of the test substance, 3. the test substance in combination with the Freundsche Adjuvans
Epidcutaneous: 20 animals received 0.5 g of the minimal irritating concentration (60 % in vaseline)-
- Control group:
Intracutaneous application: 10 animals received the Freudsche Adjuvans but not the test substance.
Epicutaneous application: 10 animals received 0.5 g of the vehicle.
- Site: to the clipped site (shoulder-back region) of the animals (intracutaneous), to the again clipped same site as during the intracutaneous induction (epicutaneous)
- Concentrations: 0.3 % in NaCl (intracutaneous), 60 % in Vaseline (epicutaneous)
- Evaluation: After 1 and 24 hours (intracutaneous and epicutaneous)
B. CHALLENGE EXPOSURE
- No. of exposures: 2 (1st: 40 % in Vaseline, 2nd: 40 % in NaCl)
- Exposure period: 24 hours
- Observations: After 24 and 48 hours
- Test groups: 20 animals: The animals got the 0.1 mL of the 40 % test substance in vaseline.
- Control group: 10 animals: Also the control group got 0.1 mL of the 40 % test substance in vaseline.
- Site: To another clipped site of the animals
- Concentrations: 0.1 mL of the 40 % solution with Vaseline
- Evaluation (hr after challenge): 24, 48 hours - Challenge controls:
- Two challenge controls were conducted, one with 40 % in Vaseline and one with 40 % in NaCl
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 40 % in Vaseline
- No. with + reactions:
- 18
- Total no. in group:
- 20
- Clinical observations:
- Not relevant for evaluation due to irritating properties of the vehicle
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 40 % in Vaseline. No with. + reactions: 18.0. Total no. in groups: 20.0. Clinical observations: Not relevant for evaluation due to irritating properties of the vehicle.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 40 % Vaseline
- No. with + reactions:
- 16
- Total no. in group:
- 20
- Clinical observations:
- Not relevant for evaluation due to irritating properties of the vehicle
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 40 % Vaseline. No with. + reactions: 16.0. Total no. in groups: 20.0. Clinical observations: Not relevant for evaluation due to irritating properties of the vehicle.
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 40 % in NaCl
- No. with + reactions:
- 4
- Total no. in group:
- 20
- Clinical observations:
- Because of irritating effects due to Vaseline a 2nd reading was done
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: 40 % in NaCl. No with. + reactions: 4.0. Total no. in groups: 20.0. Clinical observations: Because of irritating effects due to Vaseline a 2nd reading was done.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 40 % in NaCl
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- Because of irritating effects due to Vaseline a 2nd reading was done
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 40 % in NaCl. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: Because of irritating effects due to Vaseline a 2nd reading was done.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 40 % in Vaseline
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
- Not relevant for evaluation due to irritating properties of the vehicle
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 40 % in Vaseline. No with. + reactions: 8.0. Total no. in groups: 10.0. Clinical observations: Not relevant for evaluation due to irritating properties of the vehicle.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 40 % in Vaseline
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- Not relevant for evaluation due to irritating properties of the vehicle
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 40 % in Vaseline . No with. + reactions: 6.0. Total no. in groups: 10.0. Clinical observations: Not relevant for evaluation due to irritating properties of the vehicle.
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 40 % in NaCl
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 40 % in NaCl. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 40 % in NaCl
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 40 % in NaCl. No with. + reactions: 0.0. Total no. in groups: 10.0.
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