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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data are given.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Modified Buehler
GLP compliance:
no
Type of study:
Buehler test
Justification for non-LLNA method:
an in vitro or in chemico skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2-Hydroxyethylmethacrylat; HEMA
- Physical state: liquid
- Storage condition of test material: in darkness, in the refrigerator
- Other: pH 4.2

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright; sub-strain: Hoe: DHPK (SPF- LAC.) /Boe
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Lippische Versuchstierzucht
- Weight at study initiation: 226-385 g
- Housing: two animals per cage; Macrolon Plastic cages II
- Diet (e.g. ad libitum): pellets
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6-7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 deg C +/-2
- Humidity (%): 45-55%
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark; Fluorescent light, 4000 deg K, 120 Lux


IN-LIFE DATES: From: 1982-05-19 To: 1982-06-18

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.5 mL
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.5 mL
No. of animals per dose:
20- test
10- control
Details on study design:
RANGE FINDING TESTS: The highest non-irritating concentration was determined. The entire back and both sides of 4 animals were clipped one day prior to application. The following day the animals were exposed for one 6 hour period to various concentrations of the test substance. The sample was applied in four different concentrations: 100%, 75%, 50% and 25% in Aqua dest. The responses were graded at 24 and 48 hours.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hour/exposure
- Test groups: 1; 20 animals
- Control group:1; 10 animals
- Site: left flank
- Frequency of applications: once/week
- Concentrations: 0.5 mL

B. CHALLENGE EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hour/exposure
- Test groups: 1; 20 animals
- Control group: 1; 10 animals
- Site: right flank
- Concentrations: 0.5 mL
- Evaluation (hr after challenge): 24 and 48 hours

OTHER: body weights were taken at Day 0 and at the end of the entire testing period.
Challenge controls:
Previously untreated control animals from the induction phase.
Positive control substance(s):
no

Results and discussion

Positive control results:
Not applicable

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0.5 mL
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5 mL. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
There was no signs of erythema or edema observed during the testing period. According to the method, the test substance is considered to cause no delayed contact hypersensitivity.
Executive summary:

The determination of the delayed contact hypersensitivity was performed in two groups of male guinea pigs; the test group and a control group following a modified Buehler method. All animals gained weight satisfactorily during the observation period. No animals showed signs of erythema or edema. The test substance is considered to cause no delayed contact hypersensitivity.