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Diss Factsheets

Administrative data

Description of key information

The purpose of this GLP study performed according to OECD GL 406 was to assess the contact sensitisation potential of the test material in guinea pigs. The test item produced a 0 % (0/10) sensitisation rate and can therefore be assessed as a non sensitiser to guinea pig skin.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
October 04, 2006 - January 18, 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
07-1992
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Version / remarks:
not further specified
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The test material was screened for its irritating potential using the hen's egg test on the chorioallantoic membrane (HET-CAM). In this model the cumulative irritation score of the test item was 19.09, indicating strongly irritant properties. Therefore, the test item was evaluated for skin sensitizing properties in the guinea pig maximization test and not in a Local Lymph Node Assay.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Age at study initiation: 6 weeks
- Weight at study initiation: 326 - 388 g
- Housing: groups of 5 animals in type GM/5 Makrolon cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21
- Humidity (%): 49 - 77
- Photoperiod (hrs dark / hrs light): 12 / 12
Route:
intradermal
Vehicle:
paraffin oil
Concentration / amount:
cranial: 0.1 mL Freund's complete adjuvant + sodium chloride solution
medial: 0.1 mL test item (1 g/L ad liquid paraffin)
caudal: 0.1 mL Freund's complete adjuvant with test item and sodium chloride solution
Day(s)/duration:
day 0
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
epicutaneous, occlusive
Vehicle:
polyethylene glycol
Concentration / amount:
Filter patch saturated with 1 mL of the test item preparation or vehicle
Day(s)/duration:
Application on day 7 over 48 hours
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
epicutaneous, occlusive
Vehicle:
polyethylene glycol
Concentration / amount:
Filter papers fully loaded with 0.5 ml of the test item preparation and soaked with 0.5 mL PEG 400.
Topical induction: test item (10 g/L ad PEG 400)
Challenge: test item (5 g/L ad PEG 400)
Challenge: PEG 400 (undiluted)
Day(s)/duration:
day 21 over 24 hours
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
Pretest: 5 f
Number of animals in test group: 10 f
Number of animals in negative control group: 5 f
Details on study design:
To determine the concentrations suitable for the main study, a pre-test with intradermal or topical administrations of the vehicle and test item preparations was performed. Six intradermal injections with different concentrations were given to one animal. Four further animals were used to determine the topical concentrations for the main study. Two of the guinea pigs were exposed for 48 hours without pre-treatment to 4 different concentrations to determine the slightly irritating concentration for the dermal induction. The other two animals were treated according to the control group including intradermal injections with FCA. One week after topical induction the two animals of the pre-test group were exposed for 24 hours to 4 different test material concentrations to find out the non-irritating challenge concentration. In the pre-test the following concentrations were used:
Test item with liquid paraffin as vehicle:
no pre-treatment: intradermal injection: 50, 25, 10, 5, 1 and 0 g/L
Test item with polyethylene glycol 400 as vehicle:
no pre-treatment: topical exposure (48 hours): 200, 100, 50 and 10 g/L
pre-treatment with FCA: topical exposure (24 hours): 50, 10, 5 and 1 g/L

Clinical investigations
During the induction phase, the guinea pigs were examined on days 2, 3, 7, 11, 12, 15, and 22 of the experimental part for local skin reactions, and the results were documented. The behaviour and general condition of all animals were monitored daily. The challenge sites were investigated for reactions 48 hours after start of the challenge. Further inspections followed 72 hours after start of the challenge, to detect weak or slowly developing reactions.
Bodyweight
The body weight of the guinea pigs was determined prior to the start of the experimental part (day 1), on experimental days 8, 15, 22, and at the end of the experimental part.
Challenge controls:
yes
Positive control substance(s):
yes
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
positive control
Dose level:
10 g/L
No. with + reactions:
2
Total no. in group:
10
Clinical observations:
none
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
positive control
Dose level:
10 g/L
No. with + reactions:
5
Total no. in group:
10
Clinical observations:
none
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
0 g/L
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
0 g/L
No. with + reactions:
0
Total no. in group:
5
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:
5 g/L
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
5 g/L
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results of this study the test item can be assessed as a non sensitiser to guinea pig skin.
Executive summary:

Study design


The test material was screened for its irritating potential using the hen's egg test on the chorioallantoic membrane (HET-CAM). In this model the cumulative irritation score of the test item was 19.09, indicating strongly irritant properties.


Therefore, the test item was evaluated for skin sensitizing properties in the guinea pig maximization test and not in a Local Lymph Node Assay. In this GLP study performed according to OECD GL 406, guinea pigs in the negative control group treated with the vehicles and animals in the test group were investigated. Induction included intradermal injection of test material preparation in liquid paraffin both with and without Freund's complete adjuvant on experimental day 1 and topical application for 48 hours of test material preparation in polyethylene glycol 400 on experimental day 8.


Challenge by topical application for 24 hours of the test material preparation in polyethylene glycol 400 was performed two weeks after topical induction and readings taken at 48 hours and 72 hours after start of treatment.


 


Results


After challenge no positive reactions in the test material treated skin sites at both readings were seen. The clinical behavior of the guinea pigs was normal during the experimental part and all animals survived the experimental part. The body weight development corresponded to that of the animals of the vehicle group.


 


Conclusion


Under the given experimental conditions, the test item showed no positive responders and has not to be classified as a sensitizer.


 


 

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Justification for classification or non-classification

Based on the provided information there is no need for classification according to the EU Regulation (EC) No 1272/2008 on Classification, Labelling and Packaging of Substances and Mixtures.