Registration Dossier

Administrative data

Endpoint:
skin sensitisation, other
Remarks:
OECD 406
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Feb 13 - Mar 09, 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
There is adequate information from a OECD 406 study available and no OECD 429 study is thus needed to be performed.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Principles of method if other than guideline:
None
GLP compliance:
yes (incl. certificate)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
There is adequate information from a OECD 406 study available and no OECD 429 study is thus needed to be performed.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: solid

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: HsdPoc:DH
Sex:
female
Details on test animals and environmental conditions:
** Test SystemGuinea pig, HsdPoc:DH, femalesBreeder: Harlan Winkelman GmbH, Borchen Age: about 3 - 5 weeksThe mean initial body weight at the start of the study was 325 g (range from 271 to 376 g).The body weight of two animals at the start of the study was outside the range as described in the study plan (300 to 450 g). This minor deviation did not influence the outcome of the study.In a large number of tests, with a variety of test materials, the guinea pig and the specific strain used has proven to be a species well suited for skin sensitization studies.Identification and adaptionHealthy young animals were allocated to the study groups at least 7 days before dosing to allow them to acclimatize. The guinea pigs were identified by colour mark, whereas the pretest animals were marked with a different colour than the animals of group 1 and 2 (details are documented in the raw data).Assignment20 guinea pigs were used in this study.Pretest: 5 femalesGroup 1: negative control group (5 females) Group 2: test material group (10 females)- Housing:Five guinea pigs were housed in type GMI5 (EBECO) Makrolon cages with a shelter and placed on mobile racks. The animals were kept on conventional softwood granulate as the bedding. The bedding was changed two times a week.- Diet (e.g. ad libitum): Diet and community tap water from Makrolon drinking bottles were available to the guinea pigs ad libitum.The diet, Provimi Kliba 3418.0, was checked according to the specifications of the manufacturer by independent laboratories. Analysis included both qualitative and quantitative evaluation for heavy metals, aflatoxins, pesticides and antibiotics. The tap water was analyzed periodically according to the German regulations for human drinking water. The softwood granulate was analytically checked by independent laboratories.ENVIRONMENTAL CONDITIONSTemperature and atmospheric humidity were measured by a thermohygrograph. The room temperature within the study period was 22 to 23 °C and the relative atmospheric humidity 55 to 62%.

Results and discussion

Positive control results:
50% positive reactions with control substance

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
25 g/L (induction I), 7.5 g/L (induction II), 2.5 g/L (challenge)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no signs of toxicity
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
72
Group:
test group
Dose level:
25 g/L (induction I), 7.5 g/L (induction II), 2.5 g/L (challenge)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no signs of toxicity
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated informationCriteria used for interpretation of results: other: CLP
Conclusions:
Under the given experimental conditions, the test material induced no reactions. According to EU Regulation No. 1272/2008 (CLP), the test material is not classified as a skin sensitizer.
Executive summary:

Purpose

The purpose of this GPMT assay was to identify the contact allergenic potential of teh test material. This study should provide a rational basis for risk assessment to the sensitising potential of the test item in man.

Study Design

The test material was investigated for skin sensitizing properties in the guinea pig maximization test according to MAGNUSSON and KLIGMAN (1969).

5 females were treated with the vehicles liquid paraffin and polyethylene glycol 400 (group 1) and 10 females were treated with the test material (group 2).

Induction included intradermal injection of test material preparation in liquid paraffin (25 g/L with and without Freund's complete adjuvant) on experimental day 1, and topical application of test material preparation in polyethylene glycol 400 (7,5 g/L) for 48 hours on experimental day 8.

Challenge by topical application of the test material preparation in polyethylene glycol 400 (2,5 g/L) for 24 hours was performed two weeks after topical induction and readings were taken at 48 hours and 72 hours after start of treatment.

Results

The animals did not show any clinical signs during the course of the study and no cases of mortality were observed. After challange no positive reactions were seen 48 or 72 hours after treatment with the test material.

Conclusion

Under the given experimental conditions, the test material induced no reactions. According to EU Regulation No. 1272/2008 (CLP), the test material is not classified as a skin sensitizer.