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Diss Factsheets

Administrative data

Description of key information

A reliable, GLP study was conducted in guinea pigs with the read-across substance BDMAEE according to OECD Guideline 406. Based upon the observations made in the assay, BDMAEE induced at 4%, challenged at 2% and rechallenged at 1% did not cause delayed contact hypersensitivity in guinea pigs (n=20, 10 male/10 female). One vehicle control animal died during the study but the death was determined to be due to non-test related factors.

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:
1992-07 - 1992-08
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
One vehicle control animal died. However, the death of this animal was considered not to be related to treatment. This does not seem to have an impact on the reliability of the study.
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes (incl. QA statement)
Type of study:
Buehler test
Justification for non-LLNA method:
The Murine Local Lymph Node Assay (LLNA) is the first-choice method for in vivo testing according to the REACH Regulation. However, this test was performed before entry into force of the REACH Regulation.
Specific details on test material used for the study:
- Name of test material (as cited in study report): 6933-10-5
- Physical state: liquid
- Analytical purity: responsibility of the sponsor
- Stability under test conditions: no apparent change in the physical appearance of the test article during administration
- Storage condition of test material: responsibility of the sponsor
Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Buckberg Lab Animals, Tomkins Cove, New York
- Weight at study initiation: assay: 304-400g; naive control-rechallenge: 489-962g
- Age at study initiation: 4 to 6 weeks
- Housing: individually in wire mesh cages
- Diet (e.g. ad libitum): purina guinea pig diet, ad libitum
- Water (e.g. ad libitum): fresh tap water, ad libitum
- Acclimation period: minimum 5 days


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


IN-LIFE DATES: From: July 1992 To: August 1992
Route:
epicutaneous, occlusive
Vehicle:
other: 80% ethanol (induction) and acetone (challenge)
Concentration / amount:
0.3 ml/dose
induction: 4.0% (v/v)
challenge 2.0% (v/v)
rechallenge 1.0% (v/v)
Route:
epicutaneous, occlusive
Vehicle:
other: 80% ethanol (induction) and acetone (challenge)
Concentration / amount:
0.3 ml/dose
induction: 4.0% (v/v)
challenge: 2.0% (v/v)
rechallenge: 1.0% (v/v)
No. of animals per dose:
dose range: 10 (5m, 5f); test article: 20 (10m, 10f); positive control: 5 (2m, 3f); negative control: 10 (5m, 5f); naive control during rechallenge: 4 (2m, 2f)
Details on study design:
RANGE FINDING TESTS:
10 animals (5m, 5f) were each exposed to 4 different concentrations of the test material in ethanol and/or acetone (1.0, 2.0, 4.0, 6.0, 8.0, 10, and 50%)
primary challenge responses were graded
Highest non-irritatting concentration = concentration that induced responses not exceeding 2 + and 2 0 grades in the group of 4 animals.
The dose chosen for induction: 4.0%
The dose chosen for challenge: 2.0%
The dose chosen for rechallenge: 1.0%


MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 5 (3 inductions, 1challenge, 1 rechallenge)
- Exposure period: -
- Test groups: test substance in vehicle (80% ethanol)
- Control group: vehicle only
- Site: L shoulder
- Frequency of applications: once a week
- Duration: 6 h
- Concentrations: 4.0%


B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: day 30 and 37
- Exposure period: -
- Test groups: test substance in vehicle (acetone)
- Control group: vehicle only (left flank), test article (right flank)
- Site: naive site on left side
- Concentrations: 2.0% (challenge), 1.0% (rechallange)
- Evaluation (hr after challenge): 24 and 48h


OTHER:
Due to the irritation observed in the vehicle control animals at challenge, all test article-treated animals, along with an additional group of 4 naive animals were rechallenged at 1.0% (v/v) in acetone, 7 days following the primary challenge.
24h after challenge and rechallenge, all animals were depilated with Neet Cream Hair Remover (Whitehall Laboratories, Inc., New York). A minimum of 2h after depilation test sites were graded. The grading was repeated 24h later (48h grade)
All animals were euthanized by CO2 inhalation at study termination.
Challenge controls:
The negative control group was challenged with vehicle (acetone) on the left flank and test article on the right flank.
7 days after the primary challenge, all test article treated animals, along with an additional group of 4 naive guina pigs were rechallenged.
Positive control substance(s):
yes
Remarks:
1-chloro-2,4-dinitrobenzene
Positive control results:
Sensitising effects observed in all 5 animals receiving the positive control article
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
2.0%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
severity= 0.3
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
2.0%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
severity= 0.1
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
1.0%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
severity= 0.0
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
1.0%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
severity= 0.0
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.3%
No. with + reactions:
5
Total no. in group:
5
Clinical observations:
severity= 3.0
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.3%
No. with + reactions:
5
Total no. in group:
5
Clinical observations:
severity= 2.8
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
vehicle (acetone)
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
severity= 0.0
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
vehicle (acetone)
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
severity= 0.0
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
2.0%
No. with + reactions:
1
Total no. in group:
9
Clinical observations:
severity= 0.2
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
2.0%
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
severity= 0.1
Reading:
other: naive control
Hours after challenge:
24
Group:
negative control
Dose level:
1.0%
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
severity= 0.0
Reading:
other: naive control
Hours after challenge:
48
Group:
negative control
Dose level:
1.0%
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
severity= 0.0
Interpretation of results:
GHS criteria not met
Conclusions:
Based upon the observations made in the assay, the test article BDMAEE induced at 4.0%, challenged at 2.0% and rechallenged at 1.0% did not cause delayed contact hypersensitivity in guinea pigs. The substance BDMAEE is therefore not to be classified as skin sensitizer according to the CLP Regulation.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

No reliable in vivo skin sensitisation study is available with the test substance. The read-across substance BDMAEE was found to be non-sensitising in a Guinea pig maximization study.

BDMAEE induced at 4%, challenged at 2% and rechallenged at 1% did not cause delayed contact hypersensitivity in guinea pigs (n=20, 10 male/10 female). One vehicle control animal died during the study but the death was determined to be due to non-test related factors.

No further skin sensitisation study is required as the substance is classified as corrosive to the skin.

An in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available (initiated before Oct 11th, 2016).


Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on reliable in vivo skin sensitization test results, the read-across substance BDMAEE does not meet the criteria for classification as a skin sensitizer according to EU Directive 67/548/EEC and Regulation 1272/2008. The same is assumed for the test substance BAEE.