Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Referenceopen allclose all

Endpoint:
skin sensitisation: in chemico
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 (LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Justification for type of information:
For this endpoint a one-to-one read across was performed to a chemical similar compound of the same chemical class with a comparable phys. chem. profile and similar response in biological assays. The relevant study was performed according to GLP and the methods applied are fully compliant with OECD TG 429.
Regarding a full documentation we kindly refer to the pdf document provided in Chapter 13 of this dossier.
Reason / purpose for cross-reference:
read-across source
Key result
Parameter:
SI
Value:
1.6
Test group / Remarks:
Test Group 5%
Key result
Parameter:
SI
Value:
1.06
Test group / Remarks:
Test Group: 10%
Key result
Parameter:
SI
Value:
1.14
Test group / Remarks:
Test Group: 25 %
Interpretation of results:
GHS criteria not met
Conclusions:
For this endpoint a one-to-one read across was performed to a chemical similar compound of the same chemical class with a comparable phys. chem. profile and similar response in biological assays. The relevant study was performed according to GLP and the methods applied are fully compliant with OECD TG 429. The result obtained for the read across from the source compound was negative.
Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March 18 - July 06, 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
mouse local lymph node assay (LLNA)
Specific details on test material used for the study:
Batch: OS11008922
Appearance: Pale yellow powder without visible impurities
Expiry Date: 15 August 2016
Storage Conditions: At room temperature, protected from light and moisture
Purpose of Use: Industrial Chemical
Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Netherlands B.V. Postbus 6174 NL - 5960 AD Horst
- Age at study initiation: Pre-test: 9-10 weeks; Main test: 8 - 9 weeks
- Weight at study initiation: Pre-test: 20.5 g; Main test: 19.5+/- 1.5 g
- Housing: grouped per dose
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 + 2°C
- Humidity (%): 45-65%
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: day 1 To: day 6
Vehicle:
propylene glycol
Concentration:
5, 10, and 25 (w/w)
No. of animals per dose:
5
Details on study design:
RANGE FINDING TESTS:
- Compound solubility: 25% in PG
- Irritation: No
- Lymph node proliferation response: -

MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: OECD 429
- Criteria used to consider a positive response: Stimulation index > 3

Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Statistics:
Standard statistical methods have been applied for data processing.
Positive control results:
Conc. SI
0%: 1.00
5% 1.93
10% 2.65
25% 9.48
Key result
Parameter:
SI
Value:
1.6
Test group / Remarks:
Test Group: 5%
Key result
Parameter:
SI
Value:
1.06
Test group / Remarks:
Test Group: 10%
Key result
Parameter:
SI
Value:
1.14
Test group / Remarks:
Test Group: 25%
Interpretation of results:
GHS criteria not met
Conclusions:
The test item was not a skin sensitiser under the test conditions of this study.
Executive summary:

Objective


In the study the test item formulated in PG was assessed for its possible skin sensitising potential.


 


Study Design


For this purpose a local lymph node assay was performed using test item concentrations of 5, 10, and 25% (w/w).


 


Results


The animals did not show any signs of systemic toxicity or local skin irritation during the course of the study and no cases of mortality were observed.


In this study Stimulation Indices (S.I.) of 1.60, 1.06, and 1.14 were determined with the test item at concentrations of 5, 10, and 25% (w/w) in PG, respectively.


 


Conclusion


The test item was not a skin sensitiser under the test conditions of this study.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

The test item was not a skin sensitiser under the test conditions of this study.

Respiratory sensitisation

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

For this endpoint a one-to-one read across was performed to a chemical similar compound of the same chemical class with a comparable phys. chem. profile and similar response in biological assays. The relevant study was performed according to GLP and the methods applied are fully compliant with OECD TG 429. The result obtained for the read across from the source compound was negative.

Justification for classification or non-classification