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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD/EU Guideline study performed under GLP
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The present guinea pig maximisation test is availabel and was conducted before requirements for LLNA applied.
As the study is reliable and applicable, it is considered that no further testing (LLNA) is needed.
Species:
guinea pig
Strain:
other: Ibm: GOHI, synonym: Himalayan spotted
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: RCC Ltd, Biotechnology & Animal Breeding Division, Wölferstrassse 4, CH-4414 Füllinsdorf, Switzerland
- Age at study initiation: 4 - 7 weeks
- Weight at study initiation: 398 - 433 g
- Housing: individually
- Diet (e.g. ad libitum): pelleted standard provimi kliba 3418, buinea pig breeding / maintenance diet, containing Vitamin C, ad libitum
- Water (e.g. ad libitum): community tab water, ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +- 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Route:
intradermal
Vehicle:
polyethylene glycol
Remarks:
PEG 300
Concentration / amount:
Intredermal injections: 100 % Test item in vehicle
Epidermal Application: 100 % Test item in vehicle
Challange Application: 1 % Test item in vehicle
Route:
epicutaneous, occlusive
Vehicle:
polyethylene glycol
Remarks:
PEG 300
Concentration / amount:
Intredermal injections: 100 % Test item in vehicle
Epidermal Application: 100 % Test item in vehicle
Challange Application: 1 % Test item in vehicle
No. of animals per dose:
not applicable
Details on study design:
RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: intradermal: day 1 - 7, Epidermal: day 8 - 26
- Test groups: all
- Control groups: all
- Site: scapular region (appr. 6*8 cm2)
- Frequency of applications: once
- Duration: epidermal exposure: 48 hours
- Concentrations: see respective entry

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 27
- Exposure period: 24 hours
- Test groups: all
- Control group: all
- Site: left and right flank (appr. 5*5 cm2)
- Concentrations: see respective entry, right flank: vehicle only
- Evaluation (hr after challenge): 24 and 48 hours after removal
Challenge controls:
vehicle only
Positive control substance(s):
yes
Remarks:
alpha-hexylcinnamaldehyde
Positive control results:
historical data (performed from 18-Feb-2002 to 02-April-2002): valid results
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.1 % (w/w)
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
none
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.1 % (w/w)
No. with + reactions:
6
Total no. in group:
10
Clinical observations:
none
Remarks on result:
positive indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
1 % in PEG 300
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1 % in PEG300
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
vehicle
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
none
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
vehicle
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
none
Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the above mentioned findings in an adjuvant sensitization test (M&K-test) in guinea pigs, SALACOS HCISV-L does not have to be treated
as a skin sensitizer.
Executive summary:

In order to assess the cutaneous allergenic potential of SALACOS HCISV-L, the Maximization-Test was performed in 15 (10 test and 5 control) male albino guinea pigs, in accordance with OECD Guideline No. 406 and the Directive 96/54/EEC, 8.6. The intradermal induction of sensitization in the test group was performed in the nuchal region with the undiluted the test item and an emulsion of Freund's Complete Adjuvant (FCA) I physiological saline. The epidermal induction of sensitization was conducted for 48 hours under occlusion with the undiluted test item one week after the intradermal induction. The animals of the control group were intradermally induced with PEG 300 and FCA/physiological saline and epidermally induced with PEG 300 under occlusion. Nineteen days after epidermal induction the control and test animals were challenged by epidermal application of the test item at 1 % in PEG 300 and PEG 300 alone under occlusive dressing. Cutaneous reactions were evaluated at 24 and 48 hours after removal of the dressing.

Results

Skin Reactions after the Challenge Procedure

 

 after 24 hours

 after 48 hours

 

positive / total

positive / total


     C

CONTROL GROUP

 

 

SALACOS HCISV-L, 1 % in PEG 300 (left flank)

 0/5

0/5 

PEG 300 only (right flank)

0/5 

0/5 

 

 

 

TEST GROUP

 

 

SALACOS HCISV-L, 1 % in PEG 300 (left flank)

 0/10

0/10 

PEG 300 only (right flank)

0/10 

0/10 

No toxic symptoms were evident in the guinea pigs of the control or test group.

No deaths occurred.

None of the control and test animals showed skin reactions after the challenge treatment with SALACOS HCISV-L at 1 % (w/w) in PEG 300.

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

Migrated from Short description of key information:

One in vivo Study available showing no signs of sensitising properties of the substance

Justification for selection of skin sensitisation endpoint:

Only one study available. This study is well performed and rated reliable.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

Migrated from Short description of key information:

The presented substance has no indication for skin sensitisation and is therefore not a respiratory sensitiser either (REACH technical guidance document on information requirements and chemical safety assessment: scheme of R.7a, Fig 7.3-2). In addition, the substance has a low volatility (vapour pressure < 0.01 kPa).

Justification for selection of respiratory sensitisation endpoint:

No Study available and Information not requested by REACH.

Justification for classification or non-classification