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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Remarks:
The Buehler test is performed before the REACH regulation of 2016 came into force.
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study has been performed according to OECD TG 406 but not under GLP and therefore a reliability 2 is assigned.
Justification for type of information:
The Buehler test is performed before the REACH regulation of 2016 came into force. The Buehler test is considered sufficiently reliable because 100% substance has been used for induction and challenge.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
no control group used
GLP compliance:
no
Type of study:
Buehler test
Justification for non-LLNA method:
The study was performed before the LLNA method was an OECD TG method.

Test material

Reference
Name:
Unnamed
Test material form:
liquid

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
not specified
Details on test animals and environmental conditions:
Weight of animals 300g; Temp. 21°C ± 2°C; Humidity 45 - 55%

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
undiluted
Adequacy of induction:
highest technically applicable concentration used
Challenge
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
undiluted
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
20; one dose was used
Details on study design:
0.5ml of the pure substance is applied to a plaster of 19*25 mm. This was then fixed with an Elastoplaster on the left site of the animal. This area was shaved. The animal was then fixed in a holder for 6 hours. This treatment was performe twice a week for three weeks
Challenge controls:
All animals were retreated on both sides 14 days after the last treatment. Plaster was removed after 6 hours and after another 2 hours the assessment was made.
Positive control substance(s):
no

Results and discussion

Positive control results:
There are no positive or negative controls presented in the study.

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
32
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no effects
Key result
Reading:
other: check report
Group:
positive control
Remarks on result:
not measured/tested
Key result
Reading:
other: check report
Group:
negative control
Remarks on result:
other: check report

Any other information on results incl. tables

Animals showed a normal clinical appearance throughout the study. No contact hypersensitivity was observed. Skin reaction and oedema formation was observed. The redness of the skin was measured with a refractometer and was assesed with Draize score. Results: Draize score 0 - 1 for all 20 animals with remark: hair removal reaction. Results refractometer shows average values of 135 (left) and 137 (right).

Applicant's summary and conclusion

Interpretation of results:
other: Not a skin sensitiser
Remarks:
according to EU CLP (EC No. 1272/2008 and its amendments).
Conclusions:
Under the conditions of this study the test substance is not sensitizing.
Executive summary:

In a skin sensitisation study, performed similar to OECD guideline 406, twenty guinea pigs were dosed with 0.5 mL of the substance in an Elastoplaster on the left site of the animal for six hours. The treatment was repeated twice a week for three weeks. No positive control group was included in the study. Fourteen days after topical induction, challenge dosing for detection of sensitisation was performed on both left and right sides of the animals. For challenge undiluted test substance was used. The redness of the skin was measured with a refractometer and was assessed according to the Draize score. There were no deaths or clinical findings. Draize scores from 0 to 1 were observed for all 20 animals. A hair removal reaction was noted. There were no sensitisation differences between left and right side of the animals detected. No contact hypersensitivity was observed in this study.