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Diss Factsheets

Administrative data

Description of key information

No data were available for EDTMP acid and the key study was therefore read across from the sodium (6Na) salt of EDTMP (CAS 22036-77-7). A reliability 2 study in guinea pig reports the test material as not sensitising (Monsanto 1985).

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:
1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
other: Buehler test
GLP compliance:
not specified
Type of study:
Buehler test
Justification for non-LLNA method:
An LLNA study was not performed because there is an existing reliable study for skin sensitisation using the Buehler test method.
Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100% test material. Positive control induction in 80% ethanol, rechallenge in acetone as vehicle (concentration not reported).
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100% test material. Positive control induction in 80% ethanol, rechallenge in acetone as vehicle (concentration not reported).
No. of animals per dose:
The positive control group and the test material group consisted of 5 males and 5 females, and these animals were treated during the induction and challenge phases of this study. A third group was included which consisted of 3 males and 3 females, and these animals were treated only during the challenge phase to assess whether the challenge concentration was irritating.
Details on study design:
During the induction phase, the test material was applied for 6 hours and the skin was wiped free of any excess material. The treatment was repeated once a week for three weeks, for a total of three exposures. After a two week rest period, animals were treated during the first challenge phase at a new site with no previous application of test material.
Challenge controls:
Yes
Positive control substance(s):
yes
Remarks:
DNCB
Key result
Reading:
rechallenge
Group:
positive control
Dose level:
acetone as vehicle
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
greater of the 24/48 hour score
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
rechallenge
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
24/48 hour reading
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Group:
other: challenge (irritation) control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
6
Remarks on result:
no indication of skin sensitisation

0.3 ml of the test material was applied at induction and challenge as a 100% solution.

Dequest 2046 is known to have 35.7% active salt content at pH 6 -8, and a specific gravity of 1.3 -1.36 g/ cm3.

The pKa of the salt at pH 7.3 is estimated to be 6. The conversion factor to determine the salt to acid equivalent for mass for EDTMP-6Na salt is 0.768.

Therefore, based on the known active salt proportion of the substance it is calculated that the at application to animal skin amount of active salt is 400 mg, and active acid 300 mg.

Interpretation of results:
GHS criteria not met
Conclusions:
The test material was found not sensitising in a Buehler test, conducted according to an appropriate test protocol but not in compliance with GLP.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The key study (Monsanto 1985) was the most recent and reliable study available for assessment.

0.3 ml of the test material was applied at induction and challenge as a 100% solution.

Dequest 2046 is known to have 35.7% active salt content at pH 6 -8, and a specific gravity of 1.3 -1.36 g/ cm3.

The pKa of the salt at pH 7.3 is estimated to be 6. The conversion factor to determine the salt to acid equivalent for mass for EDTMP-6Na salt is 0.768.

Therefore, based on the known active salt proportion of the substance it is calculated that the at application to animal skin amount of active salt is 400 mg, and active acid 300 mg.


Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available information on the structurally analogous read across substance, sodium salt (6Na) of EDTMP (CAS 22036 -77 -7) no classification for sensitisation is required for EDTMP acid in accordance with Regulation (EC) No 1272/2008.