Bis(2-dimethylaminoethyl)(methyl)amine

Endpoint summary

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:

supporting study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

GLP compliance:

yes

Type of study:

Buehler test

Species:

guinea pig

Strain:

Hartley

Sex:

male

Details on test animals and environmental conditions:

Male Hartley albino guinea pigs obtained from Charles River Breeding Laboratories, Inc., Kingston, NY and weighing 305 to 375 g were used.
Upon arrival the animals were examined for health status by the laboratory veterinarian.
Animals were housed five per cage in rooms designed to maintain adequate environmental conditions concerning
temperature and humidity.
The animals were supplied with Purina Certified Guinea Pig Chow #5026 obtained from the Ralston Purina Co., St. Louis, MO and tap water libitum.

.Animals were acclimated to the laboratory environment for at least one week prior to study initiation. They were identified by a uniquely numbered metal eartag and randomly assigned by weight to treatment groups.
The animals were weighed at initiation and termination of the study. Routine monitoring was limited to animal husbandry procedures required to
ensure the availability of feed and water. All guinea pigs were euthanatized at study termination.

Route:

epicutaneous, occlusive

Vehicle:

polyethylene glycol

Remarks:

Polyglycol E600 (PEG 600)

Concentration / amount:

INDUCTION PHASE:
1st induction: 20 % dilution of PMDTA in PEG 600
2nd and 3rd inductions: 10 % dilution of PMDTA in PEG 600
CHALLENGE PHASE:
7.5 % of PMDTA

Route:

epicutaneous, occlusive

Vehicle:

polyethylene glycol

Remarks:

Polyglycol E600 (PEG 600)

Concentration / amount:

INDUCTION PHASE:
1st induction: 20 % dilution of PMDTA in PEG 600
2nd and 3rd inductions: 10 % dilution of PMDTA in PEG 600
CHALLENGE PHASE:
7.5 % of PMDTA

No. of animals per dose:

10 (one dose tested)

Details on study design:

A preliminary skin irritatlon screen was done in order to determine a non- irritating concentration of the test material.
A single application of 0.4 ml of 10% or 20% PMDTA in PEG 600 was topically applied to the skin of two guinea pigs for six hours.
Skin irritation readings were recorded 24 and 48 hours later; 20% dilution of PMDTA in PEG 600 was chosen for the study.

INDUCTION PHASE: The back of each guinea pig was clipped free of fur approximately 25 hours prior to study initiation. A 0.4 mi aliquot of 20% PMDTA in PEG 600 was applied to the left side of 10 guinea pigs. The chambers were secured with non-irritating tape and removed after a six-hour exposure period and observations for erythema/edema were recorded the following day. The concentration of PMDTA was decreased to 10%
for the second and third induction applications, due to erythema at the test site following the first induction.

CHALLENGE PHASE: Approx. 2 weeks after the last induction application the backs of the animals were clipped free of fur.
The concentration of PMDTA was deaeased to 7.5% for the challenge application due to erythema at the test site of some animals following the third
induction. The test material or 10% DER 331 was applied to the right side of the guinea pigs in the same manner as throughout
the induction phase. The chambers were removed after a six-hour exposure period. The following dav the application sites were depilated. The
application sites were observed and graded for sensitization response 24 and 48 hours after the challenge application. The animals were observed at random, such that treatment group was unknown. test material was considered a potential skin sensitizer if a positive response indicative of
sensitization (erythema and/or edema) was observed on two or more animals out of a total of ten animals tested.

Challenge controls:

A 10% solution of DER 331 epoxy resin was used as a positive control, it was applied to the left side during inductin phase and to the right side of the guinea pigs in the challenge phase, after clipping of fur 25 hours prior to study initiation. The chambers were secured with non-irritating tape and removed after a six-hour exposure period and the application sites were observed and graded for sensitization response 24 and
48 hours after the challenge application.

Positive control substance(s):

yes

Remarks:

10% DER 331 epoxy resin

Positive control results:

Challenge application of the positive control caused slight to moderate erythema at the test site of seven of
ten animals.

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

7.5%

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

none

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 7.5%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

7.5% PMDTA

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

none

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 7.5% PMDTA. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.

Reading:

1st reading

Hours after challenge:

24

Group:

positive control

Dose level:

10% DER 331

No. with + reactions:

5

Total no. in group:

10

Clinical observations:

erytematous response

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 10% DER 331. No with. + reactions: 5.0. Total no. in groups: 10.0. Clinical observations: erytematous response.

Reading:

2nd reading

Hours after challenge:

48

Group:

positive control

Dose level:

10% DER 331

No. with + reactions:

6

Total no. in group:

10

Clinical observations:

erytematous response

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 10% DER 331. No with. + reactions: 6.0. Total no. in groups: 10.0. Clinical observations: erytematous response.

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Based on the results of the test evaluating dermal sensitization potential of the test substance in the Hartley Albino guinea pig using Buehler method, PMDTA had no sensitising potential. These results are supported by the results of the LLNA test in mice.

Migrated from Short description of key information:
2 weeks after the induction phase (3x exposure of 10 Hartley albino guinea pigs to the test material), animals were challenged with 7.5%
PMDTA. The condition of the test sites was assessed approximately 24 and 48 hours after the challenge application. Challenge application of 7.5% PMDTA caused no significant reaction in any of the animals.

Justification for selection of skin sensitisation endpoint:
Study comparable to guideline study (Klimisch 1)

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the available data, the substance is not classified.