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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

FAT 40210 is sensitising.

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
Study period:
1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
other: Annex V, Part B of Council Directive 79/831/EEC
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Data from a reliable in vivo test conducted before the enforcement of Commission Regulation (EU) 640/2012 of 06 July 2012 amending, for the purpose of its adaptation to technical progress, Regulation (EC) No 440/2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) are available.
Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
Pirbright white strain (Tif: DHP),
10 male and 10 female animals were used in the test group and 5 male and 5 female in the control group, respectively. (initial weight was between 336 to 418 g).
The animals were housed individually in Macrolon cages(Type 3), assigned to the different groups by means of random numbers generated by the random number generator, identified by individual ear tags, kept at a constant room temperture of 22 ± 3 °C, at a relative humidity of 30 to 70 % and a 12 hours light cycle day. The animals received ad libitum standard guinea pig pellets and fresh water.
Route:
intradermal and epicutaneous
Vehicle:
physiological saline
Concentration / amount:
5 % FAT40210/D in physiological saline
Day(s)/duration:
Week 1
Route:
epicutaneous, occlusive
Vehicle:
other: vaseline
Concentration / amount:
40 % in Vaseline in epidermal induction.
Day(s)/duration:
One week after intradermal induction (week 2)
Route:
epicutaneous, occlusive
Vehicle:
other: Vaseline
Concentration / amount:
40 % in Vaseline in epidermal challenge.
Day(s)/duration:
Week 5
No. of animals per dose:
20
Details on study design:
0.1 ml of adjuvant /saline mixture, FAT 40210/D in physiological saline and FAT 40210/D in the adjuvant/saline mixture were injected simultaneously intradermal in to the shaved neck of the guinea pigs, and second induction was one week later with FAT 40210/D in vaseline was applied on a filter paper patch to the neck of the animals (patch 2x4 cm, approx 0.4 g paste per patch, occluded administration for 48 hours. Week 5, the animals were tested on the flank with FAT 40210/D in vaseline was applied (patch 2x2 cm, approx. 0.2 g paste per patch, occluded administration for 24 hours).
Challenge controls:
The group was treated with the vehicle as well as with the test articles to check the maximum subirritant concentration of the test article in adjuvant treated animals.
Positive control substance(s):
yes
Remarks:
strain sensitivity is tested once or twice per year with a known sensitizer (e.g. mercaptobenzothiazole, hexyl cinnamic aldehyde or potassium dichromate). Results of last three tests included in report.
Positive control results:
None
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
40 % in Vaseline
No. with + reactions:
1
Total no. in group:
10
Remarks on result:
other: (test article control)
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
40 % in Vaseline
No. with + reactions:
1
Total no. in group:
10
Remarks on result:
other: (test article control)
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0 (vehicle control)
No. with + reactions:
0
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0 (vehicle control)
No. with + reactions:
0
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
40 % in Vaseline
No. with + reactions:
15
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
40 % in Vaseline
No. with + reactions:
14
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
Potassium dichromate ( Intradermal induction: 0.2%, Epidermal induction: 5%, Epidermal Challenge: 1%)
No. with + reactions:
9
Total no. in group:
10
Remarks on result:
other: No reactions were seen with the side with vehicle only exposure
Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Conclusions:
FAT 40210/D was found to be a strong sensitizer in albino guinea pigs testing.
Executive summary:

A key study was performed to determined skin sensitisation of FAT 40210 according to OECD Guideline 406 (Skin Sensitisation).

75 % and 65 % of the animals were sensitized by FAT 40210/D in the test group following challenge. And according to the maximization grading FAT 40210/D showed a strong grade of skin-sensitizing (contact allergenic) potential in albino guinea pigs, which shall be classified as skin sensitizer 1B according to CLP Regulation (Regulation EC No. 1272/2008).

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

A GLP compliant study was performed to determined skin sensitisation of FAT 40210 according to OECD Guideline 406 (Skin Sensitisation). 5 % FAT40210/D in physiological saline for intradermal induction, 40 % in Vaseline in epidermal induction and 40 % in Vasiline in epidermal challenge were the doses used in the study. 75 % and 65 % of the animals were sensitized by FAT 40210/D under the experimental conditions employed. According to the maximization grading FAT 40210/D showed a strong grade of skin-sensitizing(contact allergenic) potential in albino guinea pigs, which shall be classified as skin sensitizer 1B according to CLP Regulation (Regulation EC No. 1272/2008).

The above result was supported by local lymph node assay, where the stimulation indices (SI) observed at 3, 10 and 30 % concentrations were 3.77, 6.57 and 12.53 respectively. Hence the test item is sensitising.


Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

-Skin sensitisation:

Based on the above stated assessment of the skin sensitisation potential of Reactive Black 8 (75 % of the animals sensitized in Magnuson & Kligman test) the substance needs to be classified as Skin Sens. 1B (H317: may cause an allergic skin reaction) according CLP (Regulation (EC) No 1272/2008 Of The European Parliament And Of The Council) as implementation of UN-GHS in the EU.

- Respiratory sensitisation:

As no data on respiratory sensitization is available for Reactive Black 8 a classification is not possible according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) and according CLP (Regulation (EC) No 1272/2008 Of The European Parliament And Of The Council) as implementation of UN-GHS in the EU.