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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation, other
Remarks:
in vivo study already available
Type of information:
experimental study
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:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Sodium propionate
- Source: BASF AG
- Purity: 99%
- Test substance number: 78/30

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

Study design: in vivo (LLNA)

Positive control substance(s):
not specified

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 group
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