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Description of key information

In the key reliability 1, guinea pig maximisation test (GMPT) conducted according to OECD 406 and GLP, D4 was not sensitising to the skin (Institut für Toxikologie der Bayer AG , 1985).

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
Study period:
23.07.1984 to 27.08.1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
An LLNA study was not performed because there is an existing reliable study for skin sensitisation using the Guinea Pig Maximisation test method. Furthermore, the LLNA test method is not considered to be suitable for substances that contain silicon. Please refer to the attached document for further details.
Species:
guinea pig
Strain:
other: no data; albino
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann Versuchstierzucht GmbH & Co KG, D-4799 Borchen
- Age at study initiation: No data (may have been missed in translation)
- Weight at study initiation: 425-555 g
- Housing: Groups of 3, 4 or 5 in Makrolon Type IV cages
- Diet (e.g. ad libitum): 8 kg/week for 120 animals
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Five weeks


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25
- Humidity (%): 45%
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 23.07.1984 To: 27.08.1984
Route:
intradermal and epicutaneous
Vehicle:
paraffin oil
Concentration / amount:
Induction: 100 and 1%
Challenge: 100 and 10%
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
Induction: 100 and 1%
Challenge: 100 and 10%
No. of animals per dose:
20 test group
10 negative control
Details on study design:
RANGE FINDING TESTS: Four formulations per animal (12.5, 25, 50 and 100%) were occlusively applied to the shaved flank skin (24 hours, each area approximately 2.5x2.5 cm). No further details could be translated.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Two
- Exposure period: 48 hours
- Test groups: 1% intradermally (100% in 2nd induction epicutaneously) D4 in paraffin oil, 1% (100% in 2nd induction) D4 in FCA (50% in paraffin oil)
- Control group: FCA alone, paraffin oil alone, and paraffin oil with FCA
- Site: Flank
- Frequency of applications: Weekly

B. CHALLENGE EXPOSURE
- No. of exposures: One
- Day(s) of challenge: Day 28
- Exposure period: 24 hours
- Test and control groups: 100 and 10 % D4 in paraffin oil
- Site: Flank
- Concentrations: 100 and 10%
- Evaluation (hr after challenge): 48, 72 and 96
Challenge controls:
FCA in vehicle and vehicle alone.
Positive control substance(s):
no
Positive control results:
There was no positive control in this study.
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10% or 100%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Group:
positive control
Remarks on result:
other: There was no positive control in this study.
Interpretation of results:
GHS criteria not met
Conclusions:
In a guinea-pig maximisation test (GMPT) conducted to OECD 406 and GLP (reliability score 1), D4 was not sensitising to the skin.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

In the key skin sensitisation study (GMPT) (Institut für Toxikologie der Bayer AG , 1985) albino guinea pigs were tested appropriately and in accordance with OECD test guideline 406, and to GLP. A preliminary test was conducted to determine irritancy and the concentrations to be used in the main study. Paraffin oil was used as the vehicle. In the main study 20 guinea pigs were tested with 1% D4 in paraffin oil in the first induction, and 100% D4 in the second induction. 100% and 10% (in paraffin oil) were used in the challenge phase under occlusive conditions. Ten negative control animals received the same treatment, but without D4. Evaluation of skin reactions were made at 48, 72 and 96 hours after challenge. Skin reactions in the test and control groups were all scored as zero, and therefore under the conditions of this study, D4 was not a skin sensitizer.


Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available in vivo skin sensitisation data D4 does not require classification for sensitisation according toRegulation (EC) No. 1272/2008.