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Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
From 09.02.2004 to 12.03.2004
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test method according to OECD guideline 406, but no data on GLP. No data on positive control.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
not specified
Type of study:
Buehler test

Test material

Constituent 1
Chemical structure
Reference substance name:
TCA
EC Number:
211-479-2
EC Name:
TCA
Cas Number:
650-51-1
Molecular formula:
C2HCl3O2.Na
IUPAC Name:
trichloroacetic acid
Details on test material:
- Name of test material (as cited in study report): Tricloroacetato de sodio
- Analytical purity: 99 % (w/w)

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: Young adult animals
- Housing: Animals were housed in cages groups of 5.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ºC
- Humidity (%): 60 %
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From 09.02.2004 to 12.03.2004

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
0.5 g test substance
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
0.5 g test substance
No. of animals per dose:
20 guinea pigs (10 male and 10 females)
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups: 0.5 g test substance
- Control group: 0.5 mL vehicle
- Frequency of applications: one each 7 days
- Duration: Three weeks period

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: On day 28
- Exposure period: 6 hours
- Test groups: 0.5 g test substance
- Control group: 0.5 mL vehicle
- Evaluation (hr after challenge): 30 and 45 hours

Classification system for effects: Described by Magnusson Kligman
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Hours after challenge:
30
Group:
test chemical
Dose level:
0.5 g
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: . Hours after challenge: 30.0. Group: test group. Dose level: 0.5 g. No with. + reactions: 0.0. Total no. in groups: 20.0.
Hours after challenge:
54
Group:
test chemical
Dose level:
0.5 g
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: . Hours after challenge: 54.0. Group: test group. Dose level: 0.5 g. No with. + reactions: 0.0. Total no. in groups: 20.0.
Hours after challenge:
30
Group:
negative control
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: . Hours after challenge: 30.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0.
Hours after challenge:
54
Group:
negative control
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: . Hours after challenge: 54.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0.

Any other information on results incl. tables

The results of this study show that sodium trichloroacetate does not cause skin sensitization.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
The results of this study show that sodium trichloroacetate does not cause skin sensitization.
Executive summary:

This study has been carried out with the aim of evaluating the possible sensitizer effects of the product sodium trichloroacetate on the skin of white guinea pigs (Cavia porcellus). The method of the assay has been developed according to the OECD Protocol No. 406, 1992. After initial exposure to the product being tested, animals are exposed in order to prove whether a state of hypersensitivity to the product has been induced. A group of twenty adult guinea pigs (ten female and ten males) is initially exposed (induction exposure), to three inductive applications, one every 7 days. After a three weeks period (Induction period), during which the immune response has developed, animals are exposed to a single application aimed at proving the sensitization to the product (challenge exposure). The range and degree of skin reaction after the challenge exposure are assessed by comparing this group of animals with the witness group, not treated, after their exposure to the challenge. During the assay period, environmental conditions were kept constant (Temperature: 20°C, Humidity: 60 % and Photoperiod: twelve hours light and twelve hours darkness). The results of this study show that sodium trichloroacetate does not cause skin sensitization.