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Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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:
comparable to guideline study with acceptable restrictions
Qualifier:
no guideline followed
Principles of method if other than guideline:
The test material was examined for possible irritation and sensitisation activity in an experiment with guinea pigs. The Landsteiner/Draize method was used.
The test material was administered by intradermal injections. The test animals were treated repeatedly, the controls only once.
GLP compliance:
no
Remarks:
The study pre-dates the introduction of GLP
Type of study:
other: Landsteiner/Draize method
Justification for non-LLNA method:
LLNA not available at the time of testing.
Specific details on test material used for the study:
Substance Identification: Gardamide
Species:
guinea pig
Strain:
not specified
Remarks:
albino
Sex:
male
Details on test animals and environmental conditions:
Sixteen male albino guinea pigs, weighing from 201 to 281 g, were divided into two groups of eight animals each, one test group and one control group.
No. of animals per dose:
8 per group (test animals and control)
Details on study design:
The test material was administered by intradermal injections. The test animals were treated repeatedly, the controls only once.

PRELIMINARY INVESTIGATIONS
Preliminary observations showed that a concentration of 1 % of the test material induced moderate to severe skin irritation. Therefore, a 1 % dilution of the test material in propylene glycol was used for administration. The dilution was freshly prepared once every week.

A. INDUCTION EXPOSURE
For the induction exposure a 1 % aqueous suspension of the test material was used.
Some days before starting the treatment the right flank of the animals was shaved with electric clippers. Shaving was repeated before each injection and reading if necessary.
During the induction period, the test animals received a total of 10 intradermal injections, 3 times weekly for 3 weeks. The injections were given on different spots on the right flank, within an area of 3 to 4 square cm.
As the first injection, each animal received 0.05 mL of the 1 % dilution; for the 2nd to the 10th injections, 0.1 mL per animal was applied.

B. CHALLENGE EXPOSURE
For the challenge dose a 1 % aqueous suspension of the test material was used.
Two weeks after the 10th induction injection, the challenge dose was given in an amount of 0.05 mL of the 1 % aqueous suspension per animal.
The reaction sites were examined 24 hours after the injection. Diameter, colour and thickness were used as criteria for the intensity of the reaction.
Challenge controls:
At the same time as the challenge exposure in the test animals, the control animals were injected with 0.05 mL of the 1 % aqueous suspension of the test sample. The reaction sites were examined 24 hours after the injection. Diameter, colour and thickness were used as criteria for the intensity of the reaction.
Positive control substance(s):
no
Remarks on result:
no indication of skin sensitisation

Table 1 shows the number of individual positive skin reactions observed during the induction and challenge period with the test material.

The test material caused mild to severe skin reactions upon repeated intradermal injections in all animals during the induction period. The challenge dose provoked moderate to severe reactions in all test animals and in all controls which were injected at the same time.

In general, the reactions in the controls were even more pronounced than in the test animals.

From these results it can be concluded that no sensitisation occurred after treatment with the test material.

 

Table 1: Individual Positive Reactions Observed During the Induction and Challenge Phase

Test Animals

Control Animals

Animal number

Individual direct reactions at each injection during the induction phase

Challenge

Animal number

Challenge

1

2

3

4

5

6

7

8

9

10

1836

++

++

++

++

+

++

+++

++

+++

++

++

1844

+++

1837

++

++

++

++

++

++

++

+++

+++

++

++

1845

+++

1838

+

+

++

++

++

++

+

+++

++

+++

+++

1846

+++

1839

++

+

++

+++

+

+

++

++

++

++

++

1847

++

1840

++

++

++

+

+

++

++

+

++

+++

++

1848

+++

1841

++

+

++

++

++

++

+++

+++

++

+++

++

1849

++

1842

++

++

++

++

++

+++

++

++

++

++

++

1850

+++

1843

++

+++

+++

+++

++

++

++

+++

+++

++

++

1851

+++

Degree of reaction:

+ = Mild

++ = Moderate

+++ = Severe

Interpretation of results:
GHS criteria not met
Conclusions:
Gardamide was concluded to be not sensitising in a guinea pig Landsteiner/Draize test. The study was conducted prior to the introduction of GLP or the applicable OECD test guideline.
Executive summary:

In an experiment with male albino guinea pigs, the test material was examined for sensitisation properties using the Landsteiner/Draize test.

The test material was administered by intradermal injections. The test animals were treated repeatedly, the controls only once. Preliminary observations showed that a concentration of 1 % of the test material induced moderate to severe skin irritation. Therefore, a 1 % dilution of the test material in propylene glycol was used for administration. For the challenge dose, a 1 % aqueous suspension of the test material was used.

During the induction period, the test animals received a total of 10 intradermal injections, 3 times weekly for 3 weeks. The injections were given on different spots on the right flank.

Two weeks after the 10th injection, the challenge dose was given. At the same time, the control animals were injected with the 1 % aqueous suspension of the test sample. The reaction sites were examined 24 hours after the injection. Diameter, colour and thickness were used as criteria for the intensity of the reaction.

The test material caused mild to severe skin reactions upon repeated intradermal injections in all animals during the induction period. The challenge dose provoked moderate to severe reactions in all test animals and in all controls which were injected at the same time. In general, the reactions in the controls were even more pronounced than in the test animals.

From these results, it can be concluded that no sensitisation occurred after treatment with the test material.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:
Migrated from Short description of key information:
Gardamide was found to be not sensitising in a guinea pig Landsteiner/Draize test.

Justification for selection of skin sensitisation endpoint:
Reliable in vivo study

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:
Migrated from Short description of key information:
No respiratory sensitisation study available. However, such effects are unlikely as Gardamide is not a skin sensitiser to guinea pigs and its low volatility indicates that significant inhalation is unlikely under anticipated conditions of use.

Justification for classification or non-classification

Based on the negative result a reliable in vivo skin sensitisation study, classification under the EU DSD or CLP regulations is not required.