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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
4,4'-methylenebis[N,N-bis(2,3-epoxypropyl)aniline] is methylenebisbenzenamine with four epoxy groups and is considered as a monoconstituent substance under REACH with a purity > 80% and containing the following impurities: triglycidyl-(2-hydroxy-3-chloropropyl)-methylenedianiline in a range of 3.5 to 4%, dimeric TGMDA in a range of 3 to 5%, triglycidyl-(2,3-dihydroxypropyl)-methylenedianiline in a range of 0.3 to 1%, triglycidyl-(2-hydroxypiperidine)-methylenediamine in a range of 0.5 to 1%, triglycidyl methylenedianiline in a range of 0.3 to 0.8%, (2-hydroxy-3-chloropropyl)-dimeric TGMDA in a range of 0.2 to 0.6%, and trimeric TGMDA in a range of 0.2 to 0.5%. The hypothesis is to read-across some data from the monoconstituent substance described above to the corresponding UVCB substance as described under REACH. The UVCB substance being chemically similar and just differ from the monoconstituent substance by the purity of the main constituent which is < 80% but still stay in the same order of magnitude. The impurities from the monoconstituent substance being also present in the same order of magnitude in the UVCB substance containing also two additional substances, 2-oxiranemethanamine, %{N}-[4-[[4-[[3-chloro-2-(oxiranylmethoxy)propyl](oxiranylmethyl)amino]phenyl]methyl]phenyl]-%{N}-(oxiranylmethyl)- in a range of 0.5 to 2 % and less than 1% 1-[(4-{4-[bis(oxiran-2-ylmethyl)amino]benzyl}phenyl)(oxiran-2-ylmethyl)amino]-3-[(4-{4-[(3-chloro-2-hydroxypropyl)(oxiran-2-ylmethyl)amino]benzyl}phenyl)(oxiran-2-ylmethyl)amino]propan-2-ol. The main assumption is that the minor differences in terms of percentage between the mono and UVCB substance are not significant in respect of all properties under consideration. The full report on read-across approach is attached in section 13 of the IUCLID file.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
3 male rabbits, weighing 2 - 3 kg (12 - 14 weeks old), were individually housed in metal cages, identified with ear tags, and kept at constant temperature of 20 +/- 3 °C, a relative humidity of 30-70% and at a 12 hour dark/light cycle. m They received diet and water ad libitum Body weight was recorded on days 0, 3, and 7 of the test.

Test system

Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 grams per flank of 6 cm2
Duration of treatment / exposure:
4 hours with a semi-occlusive bandage
Observation period:
Observation was daily.
Skin reactions and signs of toxicity were recorded at 1 hour, 24, 48, 72 hours , and daily afterwards,
Number of animals:
three male rabbits
Details on study design:
Irritation / corrosion was classified according to EEC guideline 83/467/1983 (Appendix 2).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 h
Score:
> 0.3 - < 0.4
Max. score:
1
Reversibility:
fully reversible within: after 7 days
Remarks on result:
other: max. score = 4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 h
Score:
> 0.3 - < 0.4
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: max. score = 4
Irritant / corrosive response data:
The resposnses were mild and the average from 3 animals was lower than minimum for classification and labelling
Other effects:
Body weight development was not adversely affected by the treatment

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Although there was erythema in 2/3 animals and oedema in 1/3 animals with a minimum score of 1, the mean value was below the threshold for classificaiton and labelling
Executive summary:

Although there was erythema in 2/3 animals and oedema in 1/3 animals with a minimum score of 1, the mean value was below the threshold for classification and labelling; the test material is minimally irritating to skin