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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: No guideline but according to Magnusson & Kligman
Reason / purpose for cross-reference:
reference to same study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
not specified
Principles of method if other than guideline:
according to Magnusson,S. and Kligman,J. Maximisation test. J. Invest. Derm. 52, 268 - 276 (1969) and Contact Dermatitis 6, 46 - 50, (1980)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
At beginning the guinea pigs were 10 weeks old (267 - 400 gm, body weight) . They were housed individually in Macrolon cages (type3) , and individually identified with ear tags. They were kept at constant room temperature (21 +/- 2°C) and a humidity of 50 +/- 10%, and on a 12 hour dark/light cycle. All animals received diet and water ad libitum.
The sensitivity of the strain was tested every 6 months with p-phenylendiamine
Route:
intradermal and epicutaneous
Vehicle:
other: acetone
Concentration / amount:
10% in acetone
Route:
epicutaneous, semiocclusive
Vehicle:
other: acetone
Concentration / amount:
10% in acetone
No. of animals per dose:
10 males and 10 females per group
Details on study design:
First induction with 0.1 ml Freund's adjuvant intradermally, and test substasnce epidermally directly on the injection site with occlusive dressing (24 hours).
Second induction week test substance epidermally applied with occlusive dressing (application sites pretreated with 10% lauryl sulfate as an open application)
Challenge: 14 days later substance applied on filter paper to the shaved flank with occlusive dressing for 24 hours.
24 and 48 hours later the skin reactions were scored
A control group received the same treatment but with out test substance.
Challenge controls:
The maximum sub-irritant concentration was used for the challenge reactions.
Positive control substance(s):
no
Statistics:
no statistics was applied
Positive control results:
performed every 6 months to prove the sensitivity of the guinea pig strain . no data in the report
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no signs of toxicity
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: 20.0. Clinical observations: no signs of toxicity.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no observations
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: 20.0. Clinical observations: no observations.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10%
No. with + reactions:
5
Total no. in group:
20
Clinical observations:
erythema and oedema reactions
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 5.0. Total no. in groups: 20.0. Clinical observations: erythema and oedema reactions.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10%
No. with + reactions:
5
Total no. in group:
20
Clinical observations:
erythema and oedema
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 5.0. Total no. in groups: 20.0. Clinical observations: erythema and oedema.
Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
Whlie 5/20 animals showed a skin reaction with oedema and erythema in the treated group no reaction were found in the control group (0/20).
The result shows that MY 720 has a weak skin sensitizing potential, which does however not lead to labelling
Executive summary:

Whlie 5/20 animals showed a skin reaction with oedema and erythema in the treated group no reaction were found in the control group (0/20). The result shows that MY 720 has a weak skin sensitizing potential, which does however not lead to labelling

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

The tests in Guinea pig showed a weak potential to cause skin sensitization. This has also been observed in workers exposed to the compound as shown in chapter 7.10.4.

Most epoxy compounds have a potential to cause skin sensitization, if sufficiently soluble in water or organic solvents. This is also the case for TGMDA which has 4 epoxid groups.


Migrated from Short description of key information:
A modified maximization test was performed.The substance is considered to be a weak skin sensitizer

Respiratory sensitisation

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

TGMDA is a skin sensitizier in animals and man. However, no test for respiratory sensitization has been conducted in animals and no case reports are available indicating that this substance is a respiratory sensitizer in Humans.

In addition, none of the industrial epoxides used at high tonnage levels have indicated that they are respiratory sensitizers despite the fact that all are skin sensitizers

In the absence of such data it has to be assumed that TGMDA is devoid of a respiratory sensitization potential.


Migrated from Short description of key information:
No respiratory sensitization tests can be eprformed as there is no validated test system available. Based on experience with other epoxy compounds, respiratory sensitization is rather unlikely, as for only few epoxy compounds case reports are available indicating that respiratory sensitization has occurred in the past.

Justification for classification or non-classification

Based on its potential to cause skin sensitization in animals and man, TGMDA is classified as Xi, R43 for skin sensitization.

No classification and lebelling is requierd for respiratory sensitization as this is unlikely and, in the absence of relevant data, not justified.