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Diss Factsheets

Administrative data

Description of key information

The read across for substance, CAS: 70851-04-6; EC: 453-480-2; is based upon the analogous substances to which basic form, degree of substitution  of functional groups is not considered to effect the proposed read across for the endpoint skin sensitisation. Based on the information available for the read across substances, the substance is not expected to be a skin sensitiser.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Composition of test substance unclear.
Principles of method if other than guideline:
Local Lymph Node Assay was performed in mice to investigate the skin sensitizing potential of the test substance.
GLP compliance:
not specified
Type of study:
mouse local lymph node assay (LLNA)
Species:
mouse
Strain:
other: CBA/Ca
Sex:
female
Vehicle:
other: Acetone
Concentration:
3%, 10% and 30%
No. of animals per dose:
4
Details on study design:
MAIN STUDY
- Name of test method: ß-scintillation counting
- Criteria used to consider a positive response:
1. The increase in isotope incorporation for at least one concentration tested must be three-fold or more compared to the control (vehicle treated) mice.
2. The data generated must be compatible with the biological dose response.

TREATMENT PREPARATION AND ADMINISTRATION:
Samples were administered to the dorsum of both ears using a micro-pipette.
Groups of 4 female mice were dosed with 25 µl of either vehicle (acetone) or a 30%, 10% or 3% preparation of the test item on three consecutive days on the dorsum of both ears. Five days after initial dosing, the animals received approx. 20 µCi of 3H-methyl thymidine, were sacrificed 5 h later and radioactive counts/lymph node were measured.
Key result
Parameter:
SI
Remarks on result:
other: The stimulation index was 0.45 for the 3% application, 2.05 for 10% and 1.21 for the 30% application.
Key result
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: No significant increase in isotope incorporation was detected after repeated application. The Cpm (Counts per minute) was 0.0022 Cpm and 0.0047 for the vehicle controls and 0.001, 0.0045 and 0.0057 for 3%, 10% and 30%, respectively.

Table 1: Results of the ß-scintillation counting

Test Concentration

Cpm/Lymph Node (x 10-2)

Test/Control Ratio

Vehicle

0.22

-

3% w/v

0.10

0.45

10% w/v

0.45

2.05

Vehicle

0.47

-

30% w/v

0.57

1.21
Interpretation of results:
other: inconclusive
Remarks:
Criteria used for interpretation of results: EU
Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Significant methological deficiencies (only basic study data reported, no positive control, only 2 concentrations tested, test substance not defined).
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
yes
Remarks:
(only basic study data reported, no positive control, only 2 concentrations tested, test substance not defined)
GLP compliance:
not specified
Type of study:
mouse local lymph node assay (LLNA)
Species:
mouse
Strain:
other: CBA/Ca
Sex:
female
Details on test animals and environmental conditions:
No Data
Vehicle:
other: Acetone
Concentration:
3% or 10%
No. of animals per dose:
4
Details on study design:
MAIN STUDY
- Name of test method: ß-scintillation counting
- Criteria used to consider a positive response:
1. The increase in isotope incorporation for at least one concentration tested must be three-fold or more compared to the control (vehicle treated) mice.
2. The data generated must be compatible with the biological dose response.

TREATMENT PREPARATION AND ADMINISTRATION:
Groups of 4 female mice were dosed with 25 µl of either vehicle (acetone) or a 10% or 3% preparation of the test item on three consecutive days on the dorsum of both ears. Five days after initial dosing, the animals received approx. 20 µCi of 3H-methyl thymidine, were sacrificed 5 h later and radioactive counts/lymph node were measured.
Key result
Parameter:
SI
Remarks on result:
other: The stimulation index was 3.13 for the 3% application and 6.87 for the 10% application.
Key result
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: A significant increase in isotope incorporation was detected after repeated application. The Cpm (Counts per minute) increased dose-dependently from 0.0015 Cpm (Vehicle) to 0.0047 and 0.0103 for 3% and 10%, respectively.

Table 1: Results of the ß-scintillation counting

Test Concentration

Cpm/Lymph Node (x 10-2)

Test/Control Ratio

Vehicle

0.15

-

3% w/v

0.47

3.13

10% w/v

1.03

6.87

The increase in radioactive counts/lymph node seen between vehicle and 3% and 10% of the test compound implies a sensitizing potential. Only two concentrations were tested preventing a conclusive interpretation.

Interpretation of results:
other: inconclusive
Remarks:
Criteria used for interpretation of results: EU
Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only short summary available (no data on test substance purity).
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
yes
Remarks:
Only summary provided, no data on test substance purity
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)
Species:
other: No Data
Strain:
not specified
Sex:
not specified
Vehicle:
not specified
Concentration:
1%, 3% and 10%
No. of animals per dose:
No Data
Key result
Parameter:
SI
Remarks on result:
other: The stimulation index was 1.3 for the 1% application, 1.19 for 3% and 1.54 for the 10% application.
Key result
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: No significant increase in isotope incorporation was detected after repeated application. The Cpm (Counts per minute)/Lymph node was 0.011 Cpm for the vehicle control and 0.0143, 0.0131 and 0.017 for 1%, 3% and 10%, respectively.

Table 1: Results of the ß-scintillation counting

Test Concentration

Cpm/Lymph Node (x 10-2)

Test/Control Ratio

Vehicle

1.1

-

1% w/v

1.43

1.3

30% w/v

1.31

1.19

10% w/v

1.7

1.54

The test substance is unlikely to be a sensitiser under the conditions of the test.

Interpretation of results:
other: inconclusive
Remarks:
Criteria used for interpretation of results: EU
Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (no information on purity of the test material; both flanks were exposed during challenge, no reliability check done, no positive control used. Method given in very summarized form).
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
no information on purity of the test material; both flanks were exposed during challenge, no reliability check done, no positive control used. Method given in very summarized form.
GLP compliance:
not specified
Type of study:
Buehler test
Justification for non-LLNA method:
A valid test was available from 1991 (before REACH came into force), therefore no additional LLNA test was performed.
Species:
guinea pig
Strain:
other: Albino
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 344 - 441 g
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
Induction: 100%
Challenge: 30% and 100%
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
Induction: 100%
Challenge: 30% and 100%
No. of animals per dose:
20 (10 for the controls)
Details on study design:
RANGE FINDING TESTS: No Data

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Test groups: Undiluted test sample
- Control group: not stated
- Site: scapular region
- Frequency of applications: 7 d interval
- Duration: 14 d
- Concentrations: undiluted

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 28, 14 d after final induction
- Exposure period: 6 h
- Test groups: undiluted (100%) and 30% (w/v in corn oil)
- Control group: undiluted (100%) and 30% (w/v in corn oil)
- Site: undiluted (100%) on left flank and 30% on right flank
- Concentrations: undiluted (100%) and 30% (w/v in corn oil)
- Evaluation (hr after challenge): 24 h and 48 h
Challenge controls:
No
Positive control substance(s):
no
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
Key result
Group:
positive control
Remarks on result:
not measured/tested
Interpretation of results:
not sensitising
Conclusions:
CLP: not classified
DSD: not classified
Endpoint:
skin sensitisation
Type of information:
(Q)SAR
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Justification for type of information:
QSAR prediction
Guideline:
other: REACH guidance on QSARs R.6, May/July 2008
Principles of method if other than guideline:
(Q)SAR conducted with OECD Application Toolbox; Version 1.1.02

Reading: other: QSAR prediction. Group: other: QSAR prediction. Clinical observations: negative for skin sensitization .

Interpretation of results:
GHS criteria not met
Endpoint:
skin sensitisation, other
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Remarks:
1 substances available for read-across
Adequacy of study:
weight of evidence
Justification for type of information:
see the attached justification in Section 13 for full details
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Remarks:
CAS 68424-31-7 (1991a)
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Remarks:
CAS 68424-31-7 (1991a)
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Remarks:
CAS 68424-31-7 (1991a)
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
Remarks:
CAS 68424-31-7 (1991a)
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
Remarks:
CAS 68424-31-7 (1991a)
Key result
Group:
positive control
Remarks on result:
not measured/tested
Remarks:
CAS 68424-31-7 (1991a)
Key result
Parameter:
SI
Remarks on result:
other: The stimulation index was 0.45 for the 3% application, 2.05 for 10% and 1.21 for the 30% application.
Remarks:
(1991b)
Key result
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: No significant increase in isotope incorporation was detected after repeated application. The Cpm (Counts per minute) was 0.0022 Cpm and 0.0047 for the vehicle controls and 0.001, 0.0045 and 0.0057 for 3%, 10% and 30%, respectively.
Remarks:
(1991b)
Key result
Parameter:
SI
Remarks on result:
other: The stimulation index was 1.3 for the 1% application, 1.19 for 3% and 1.54 for the 10% application.
Remarks:
CAS 68424-31-7 (1992)
Key result
Parameter:
other: disintergrations per minute (DPM)
Remarks on result:
other: No significant increase in isotope incorporation was detected after repeated application. The Cpm (Counts per minute)/Lymph node was 0.011 Cpm for the vehicle control and 0.0143, 0.0131 and 0.017 for 1%, 3% and 10%, respectively.
Key result
Parameter:
SI
Remarks on result:
other: The stimulation index was 3.13 for the 3% application and 6.87 for the 10% application.
Remarks:
CAS 68424-31-7 (1991c)
Key result
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: A significant increase in isotope incorporation was detected after repeated application. The Cpm (Counts per minute) increased dose-dependently from 0.0015 Cpm (Vehicle) to 0.0047 and 0.0103 for 3% and 10%, respectively.
Remarks:
CAS 68424-31-7 (1991c)

Reading: other: QSAR prediction. Group: other: QSAR prediction. Clinical observations: negative for skin sensitization . (CAS 68424 -31 -7 OECD Toolbox 2010)

Interpretation of results:
GHS criteria not met
Conclusions:
The read across for substance,CAS: 70851-04-6; EC: 453-480-2; is based upon the analogous substances to which basic form, degree of substitution of functional groups is not considered to effect the proposed read across for the endpoint skin sensitisation. Based on the information available for the read across substances, the substance is not expected to be a skin sensitiser.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The read across for substance, CAS: 70851-04-6; EC: 453-480-2 is based upon the analogous substances to which basic form, degree of substitution  of functional groups is not considered to effect the proposed read across for the endpoint skin sensitisation. Based on the information available for the read across substances, the substance is not expected to be a skin sensitiser.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

All available data on skin sensitisation do not meet the classification criteria according to Regulation (EC) 1272/2008.