Registration Dossier
Registration Dossier
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EC number: 204-638-2 | CAS number: 123-62-6
Skin sensitisation
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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline with acceptable restrictions (no positive control group, lesser animals (test group), lesser application volume during induction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- (no positive control group, lesser animals (test group), lesser application volume during induction)
- Principles of method if other than guideline:
- Method: according to the method described by Magnusson and Kligmann "Allergie contact dermatitis in the guinea pig" Ed. Ch.C. Thomas, Springfield, Illinois, USA (1970)
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study was conducted before the LLNA existed
Test material
- Reference substance name:
- Sodium propionate
- EC Number:
- 205-290-4
- EC Name:
- Sodium propionate
- Cas Number:
- 137-40-6
- Molecular formula:
- C3H6O2.Na
- IUPAC Name:
- sodium propionate
- Details on test material:
- - Name of test material (as cited in study report): Natrium propionate
- Source: BASF AG
- Purity: 99%
- Test substance number: 78/30
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: albino SPF guinea pigs
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Central Institute for the Breeding of Laboratory Animals TNO, Zeist, The Netherlands
- Age at study initiation: young
- Sex: male
- Weight at study initiation: 200-300g
- Housing: in suspended stainless steel cages, fitted with wire mesh floors and fronts
- Diet: ad libitum; stock diet enriched with vitamin C
- Water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 ± 10
- Humidity (%): 45 ± 5
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Induction: water and vaseline for intradermal and topical induction, respectively. Challenge: vaseline
- Concentration / amount:
- Induction: 2% (intradermal), 20% (topical)
challenge: 20% (topical)
Challengeopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- other: Induction: water and vaseline for intradermal and topical induction, respectively. Challenge: vaseline
- Concentration / amount:
- Induction: 2% (intradermal), 20% (topical)
challenge: 20% (topical)
- No. of animals per dose:
- Control: 10
treated animals: 6 - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal Injection:
- Site: shoulder
- Concentration: 2% (0.05 ml/site)
- Vehicle: distilled water
- Test group 1: Freund's complete adjuvant (FCA)
- Test group 2: The test article in distilled water
- Test group 3: Freund's complete adjuvant and test article in distilled water (1:1)
- Control group 1: Freund's complete adjuvant (FCA) 1:1 with physiological saline (0.9%).
- Control group 2: Distilled water
- Control group 3: Freund's complete adjuvant and distilled water (1:1)
- Frequency of applications: 1x, 2 injections/dose
- Evaluation (hr after injection): no data
Topical Induction Exposure:
- Time Schedule: about 1 week after intradermal injections
- Concentration: 20% in vaseline
- Route of exposure: epicuteneous, patches of whatman filter paper (2 x 4 cm) saturated with the test substance
- Type of coverage: occlusive
- Duration: 48h.
- Evaluation (hr after injection): no data
B. CHALLENGE EXPOSURE
Test groups and control group treated identically in the following manner
- Day(s) of challenge: 2 weeks after topical induction exposure
- Route of exposure: epicutaneous, applied to an area of about 2 x 2cm; A small amount of the mixture was applied to the shaved area of each animal and gently massaged in with a glass rod for about 30 seconds
- Duration: 24 h
- Concentration: 20%,
- Vehicle: vaseline
- Evaluation (hr after challenge): 24h, scoring of findings using Draize score system for scoring skin irritation
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 20% in vaseline
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No clinical signs occurred
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 20% in vaseline. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No clinical signs occurred.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20% in vaseline
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- No clinical signs occurred
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 20% in vaseline. No with. + reactions: 0.0. Total no. in groups: 6.0. Clinical observations: No clinical signs occurred.
Any other information on results incl. tables
- All animals remained in good health during the experiment and gained weight.
INDUCTION
- Intradermal
The intra-dermal injections of each of the three test substances given in the induction phase of the study resulted in the following reactions:
1. Freund's Complete Adjuvant : erythema -2, edema -2
2. 2 % Luprosil in water :caused no visible reaction upon intradermal injection
3. 2% Luprosil in Adjuvant and water (1 :1) : erythema, edema.
- Topical
The topical application of the test substances in a 20% mixture with vaseline during the induction period did not result in erythema or edema or produced only very slight erythema
CHALLENGE
The challenge dose the test substances provoked neither erythema nor edema in the test animals and in the controls.
From these results it is concluded that under the conditions of' this experiment the Luprosil salt (78/28) did not induce sensitization
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
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