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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:
weight of evidence
Study period:
May 15, 1992 to July 10, 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD 406 guideline study performed according to GLP regulation
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Testing commisioned prior to REACH regulation
Species:
guinea pig
Strain:
other: Pirbright White Strain (Tif: DHP)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ciba-Geigy Limited Animal Production 4332 Stein Switzerland
- Weight at study initiation: 347 to 432 g
- Housing: Individually in Macrolon type 3 cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 26 May 1992 to 31 May 1992


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30 to 70
- Photoperiod (hrs dark / hrs light): 12 / 12


IN-LIFE DATES: From: June 01, 1992 To: July 02, 1992
Route:
intradermal and epicutaneous
Vehicle:
other: Oleum arachidis and an adjuvant/saline mixture were used for the intradermal induction. Vaseline was used for the epidermal induction as well as for the challenge procedure.
Concentration / amount:
The substance at 3% in Oleum arachidis during the intradermal induction.
The undiluted substance (50%) was used during the epidermal induction.
The substance at 30% in vaseline was used during the challenge procedure.
Route:
epicutaneous, occlusive
Vehicle:
other: Oleum arachidis and an adjuvant/saline mixture were used for the intradermal induction. Vaseline was used for the epidermal induction as well as for the challenge procedure.
Concentration / amount:
The substance at 3% in Oleum arachidis during the intradermal induction.
The undiluted substance (50%) was used during the epidermal induction.
The substance at 30% in vaseline was used during the challenge procedure.
No. of animals per dose:
10 control animals (5 males and 5 females)
20 test animals (10 males and 10 females)
Details on study design:
RANGE FINDING TESTS:
The substance at 1, 3 and 5% in Oleum arachidis was tested for the intradermal induction. Necrosis was noted at 5%. Therefore 3% was selected for the intradermal induction in the main study.
The substance at 1, 5, 10, 30, 40 and 50% in vaseline was tested for the epidermal induction. Erythema was noted at 40% and 50%. Therefore, 50% was selected for the epidermal induction and 30% was selected for the challenge procedure.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: one intradermal exposure and one epidermal exposure
- Exposure period: First induction week: intradermal induction
Second induction week: epidermal induction
- Test groups:
Intradermal Induction:
1) adjuvant / saline mixture 1:1 (v/v)
2) substance at 3% in Oleum arachidis (w/v)
3) substance at 3% in adjuvant/saline mixture (w/v)
Epidermal Induction:
The substance at 50% in vaseline.
- Control group:
The control animals were treated with adjuvant and vehicle during the induction period.
- Site: The intradermal induction was performed on the sahved neck of the guinea pigs. The epidermal induction was performed over the injection sites.
- Frequency of applications: One week after the intradermal induction injections the epidermal induction application was performed.
- Duration:
Three pairs of intradermal injections made simultaneously for the intradermal induction.
Colsed patch exposure for 48 hours for the epidermal induction.
- Concentrations:
0.1 mL of the substance at 3% for the intradermal induction
0.4 g of the substance at 50% in vaseline for the epidermal induction

B. CHALLENGE EXPOSURE
- No. of exposures: single
- Day(s) of challenge: week 5
- Exposure period: 24 hours
- Test groups:
The animals were treated with the substance in vaseline (w/w) and the vehicle alone by occluded administration.
- Control group:
The animals were treated with the vehicle alone as well as with the maximum subirritant concentration of the substance
- Site: Flank
- Concentrations: 0.2 g of the substance at 30% in vaseline
- Evaluation (hr after challenge): 24 hours and 48 hours after removal of the dressings.
Positive control substance(s):
yes
Remarks:
Potassiumdichromate
Positive control results:
Seven out of ten animals after 24 hours and six out of ten animals after 48 hours showed positive skin reactions after the challenge procedure with potassiumdichromate at 1% in vaseline, no skin effects were noted in the test animals when treated with the vehicle alone. No skin effects were noted in control group when treated with potassiumdichromate at 1% in vaseline or with the vehicle alone.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
vehicle
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: vehicle. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
vehicle
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: vehicle. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
30%
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: 30%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
30%
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: 30%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
vehicle
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: vehicle. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
vehicle
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: vehicle. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
30%
No. with + reactions:
19
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 30%. No with. + reactions: 19.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
30%
No. with + reactions:
19
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 30%. No with. + reactions: 19.0. Total no. in groups: 20.0.
Reading:
1st reading
Group:
positive control
No. with + reactions:
0
Total no. in group:
0
Remarks on result:
not measured/tested
Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
95% of the test animals were sensitised under the experimental conditions employed. The test material is considered to be an extreme skin sensitiser in albino guinea pigs.
Executive summary:

In order to assess the cutaneous allergenic potential of the substance, the Maximization-Test was performed in 30 (20 test and 10 control) males and females albino guinea pigs, in accordance with OECD Guideline No. 406 and the Directive 84/449/EEC, B.6.

The intradermal induction of sensitization in the test group was performed in the nuchal region with a 3% dilution of the test material in Oleum arachidis and in mixture of Freund's Complete Adjuvant (FCA) / physiological saline. The epidermal induction of sensitization was conducted for 48 hours under occlusion with the test item at 50 % in vaseline one week after the intradermal induction. The animals of the control group were induced with the vehicle and Freund's Complete Adjuvant.

Two weeks after epidermal induction the control and test animals were challenged by epidermal application of the test item at 30 % in vaseline and vaseline alone under occlusive dressing.

Cutaneous reactions were evaluated at 24 and 48 hours after removal of the dressing.19 out of 20 animals (95%) after 24 and 48 hours showed positive skin reactions after the challenge procedure with the substance at 30% in vaseline, no skin effects were noted in the test animals when treated with the vehicle alone. No control animal showed effects when treated with the substance at 30% in vaseline or when treated with vaseline alone. Based on the above mentioned findings the test material is considered to be a skin sensitiser.

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

Bis(2,3 -epoxypropyl) terephthalate and tris(oxiranylmethyl) benzene-1,2,4 -tricarboxylate, which are the main constituents of the substance, were both tested seperately in a Magnusson & Kligman test according to OECD 406.

As both compound showed a significant potential to cause skin sensitisation, the substance reaction mass of bis(2,3 -epoxypropyl) terephthalate and tris(oxiranylmethyl) benzene-1,2,4 -tricarboxylate can also be considered as a skin sensitiser.


Migrated from Short description of key information:
Both bis(2,3 -epoxypropyl) terephthalate and tris(oxiranylmethyl) benzene-1,2,4 -tricarboxylate which are the main compounds of the substance were tested in a Magnusson & Kligman test and showed a significant potential to cause skin sensitisation.

Justification for selection of skin sensitisation endpoint:
Main constituents of Reaction mass of bis(oxiran-2-ylmethyl) terephthalate and tris(oxiran-2-ylmethyl) benzene-1,2,4-tricarboxylate are both sensitising to the skin.

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, the substance needs to be classified as R43 (May cause sensitisation by skin contact)according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) and accordingCLP (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 the substance a classification is not possible according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) and accordingCLP (Regulation (EC) No 1272/2008 Of The European Parliament And Of The Council)as implementation of UN-GHS in the EU.