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Diss Factsheets

Administrative data

Description of key information

Not sensitising; based on read-across from supporting substance (structural analogue or surrogate).

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Study period:
01 Nov 1995 - 01 Dec 1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP-guideline study with acceptable restrictions (during induction phase the scapolar region was treated instead of flank; during challenge the right and left top flank were treated with test substance; details on positive control not given)
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
During the induction phase the scapolar region was treated instead of flank; during challenge the right and left top flank were treated with the test substance; no details on the positive control given
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
Available study data 12+ years
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River UK, Ltd, Manston Rd, Margate, Kent or Harlan Porcellus, Firgrove Farm, Cross-in-Hand, Heathfield, Sussex, UK
- Weight at study initiation: 250-450 g
- Housing: not further specified
- Diet: RGP Guinea Pig diet supplied by Labsure, Lavender Mill, Manea, Cambridgeshire, UK
- Water: mains
- Acclimation period: at least 6 days prior to dosing

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 ±2
- Humidity (%): 55 ±15
- Air changes (per hr): 25-30 per hour
- Photoperiod (hrs dark / hrs light): 12 / 12
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
100%
Day(s)/duration:
Day 1/6h
Adequacy of induction:
not specified
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
100%
Day(s)/duration:
Day 28/6 h
Adequacy of challenge:
not specified
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
30%
Day(s)/duration:
Day 28/6 h
Adequacy of challenge:
not specified
No. of animals per dose:
10 (control), 20 (in test groups)
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Test groups: test substance
- Control group: corn oil
- Site: scapular region
- Frequency of applications: every 7 days
- Duration: Days 0-14
- Concentrations: 100%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 28
- Exposure period: 6 h
- Test groups: test substance in corn oil
- Control group: test substance in corn oil
- Site: top left flank (test substance 100%) and top right flank (test substance 30%)
- Concentrations: 100% and 30%
- Evaluation (hr after challenge): 24 and 48 h after patch removal
Positive control substance(s):
yes
Remarks:
not specified
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100%
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
Scattered mild redness
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified
Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Study period:
13 Sep - 02 Oct 2006
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP - Guideline study. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Version / remarks:
adopted in 2002
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
Version / remarks:
adopted in 2004
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
Version / remarks:
adopted in 2003
Deviations:
no
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)
Species:
mouse
Strain:
other: CBA strain, inbred, SPF-Quality
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River France, L´Arbresle Cedex, France
- Age at study initiation: approx. 11 weeks old
- Weight at study initiation: 20-25 g (females)
- Housing: individual housing in labelled Macrolon cages (MI type) containing sterilized sawdust as bedding material
- Diet: pelleted rodent diet, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3
- Humidity (%): 30 - 70 (relative humidity); 40 – 70 (actual range)
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: 13 Sept 2006 To: 02 October 2006
Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
25, 50 and 100%
No. of animals per dose:
5
Details on study design:
RANGE FINDING TESTS:
- Irritation: a preliminary irritation study (range-finding study) was run in order to select the highest test substance concentration to be used in the main study.
A series of two test substances concentrations was tested, selected from the series: 100% (undiluted), 50%, 25%, 10%, 5%, 2.5%, and 1% and if needed further lower concentrations using the same steps. The test system, procedures and techniques were identical to those used during days 1 to 3 of the main study unless otherwise specified.
2 young adult animals were selected (5-14 weeks old). Each animal was treated with one concentration on 3 consecutive days.
Approximately 4 hours after the last exposure, the ear was cleaned of residual test substance with tap water and the irritation was assessed. Body weight were recorded on day 3.

At 50% dose concentration a grade 2 erythema (well defined erythema) was observed in 1 animal on the left and right dorsal surface ear. At 100% dose concentration a grade 1 erythema (slight erythema) was observed in the other animal on the left and right dorsal surface area. Based on the results, the highest test substance concentration selected for the main study was 100% concentration.

MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: ³H-methyl thymidine incorporation determined by ß-scintillation
- Criteria used to consider a positive response: DPM (disintegration per minutes) values were presented for each animal and for each dose group. A stimulation index (SI, ratio of the DPM/ treated group compared to DPM/vehicle control group) was calculated for each group. If the results indicate a SI ≥ 3, the test substance was regarded as a skin sensitizer.

TREATMENT PREPARATION AND ADMINISTRATION: 25 µL of test substance was applied to the dorsal surface of each ear of each mouse. The application was repeated on Days 2 and 3. On Day 6 an injection of 250 µL phosphate buffered saline (PBS) containing 20 µCi of ³H-methyl thymidine (³H-TdR) was made into the tail vein of each experimental mouse. Five hours later, the draining auricular lymph node of each ear was excised in PBS. A single cell suspension of lymph node cells (LNC) was prepared in PBS by gentle separation through stainless steel gauze (diameter 125 µm). LNC were washed twice with an excess of PBS by centrifugation at 200 g for 10 minutes at 4 °C. To precipitate the DNA, the LNC were exposed to 5% trichloroacetic acid (TCA) at 4 °C during the night.
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Statistics:
Linear interpolation was used to calculate EC3 value for positive control concentrations
Positive control results:
Mean DPM/animal values for the experimental groups treated with positive control concentrations 5, 10 and 25% were 324, 621, and 1145 respectively.The SI values calculated for the alpha-hexylcinnamic aldehyde concentrations 5, 10 and 25% were 1.6, 3.0 and 5.5 respectively. An EC3 value of 10.0% was calculated using linear interpolation.
Key result
Parameter:
SI
Value:
1.1
Test group / Remarks:
25%
Key result
Parameter:
SI
Value:
0.9
Test group / Remarks:
50%
Key result
Parameter:
SI
Value:
2.3
Test group / Remarks:
100%

Slight irritation was noted among the animals of the control group and in all animals treated at 25%. Slight or well-defined irritation was noted among the animals of the higher dose groups.

 

Table 1: Skin reactions, body weights and relative size auricular lymph nodes

Group

%Test substance

Animal

Day 3

Day 6

 

 

 

Skin reactions dorsal surface ear

Size nodes

 

 

 

left

right

 

 

 

 

erythema

oedema

erythema

oedema

left

right

1

0% (vehicle)

1

0

0

0

0

n

n

 

 

2

0

0

1

0

n

n

 

 

3

0

0

1

0

n

n

 

 

4

0

0

0

0

n

n

 

 

5

0

0

1

0

n

n

 

25%

6

1

0

1

0

n

n

 

 

7

0

0

1

0

n

n

 

 

8

0

0

1

0

n

n

 

 

9

0

0

1

0

n

n

 

 

10

1

0

1

0

n

n

 

50%

11

1

0

2

0

n

n

 

 

12

1

0

1

0

n

n

 

 

13

1

0

2

0

n

-

 

 

14

1

0

1

0

n

n

 

 

15

1

0

1

0

-

n

 

100%

16

0

0

1

0

n

-

 

 

17

1

0

2

0

n

n

 

 

18

1

0

1

0

n

n

 

 

19

1

0

1

0

n

n

 

 

20

1

0

2

0

n

n

n= considered to be normal

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified
Endpoint:
skin sensitisation: in vivo (non-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:
other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Justification for type of information:
Please see attached justification for read across in Section 13.
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:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: CAS 68855-18-5
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100%
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
Scattered mild redness
Remarks on result:
other: CAS 68855-18-5
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: CAS 68855-18-5
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: CAS 68855-18-5

Results from CAS 91031-85-5 in vivo (LLNA)

Parameter       Value              Test group / Remarks

SI                     1.1               25%

SI                     0.9               50%

SI                     2.3               100%

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

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

According to the Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures, the substance does not have to be classified and has no obligatory labelling requirement for sensitisation.