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Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP conform study following protocol identical to OECD 406 guideline. Well reported and documented. The study is considered to be reliable as no relevant deficiencies have been detected.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
The Buehler test is an accepted method for hazard identification of skin sensitising substances as recommended in "ECHA guidance R.7a: Endpoint specific guidance".

Test material

Constituent 1
Chemical structure
Reference substance name:
boranylidyneamine
EC Number:
701-292-9
Cas Number:
10043-11-5
Molecular formula:
BN
IUPAC Name:
boranylidyneamine
Details on test material:
- Name of test material (as cited in study report): 89-006 (UHP 2020)
- Substance type: inorganic
- Physical state: solid
- Analytical purity: < 98.5 %
- Impurities (identity and concentrations): B2O3 0.1 %, carbon 0.4 %, ammonia 90 ppm, lead 20 ppm
- Stability under test conditions: stable
- Storage condition of test material: room temperature in plastic bag
- Particle size: D50 4.3 µm

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Murphy Breeding Laboratories Inc.
- Weight at study initiation: 390-621 g
- Housing: individually in wire mesh suspension cages
- Diet (e.g. ad libitum): purina guinea pig chow ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 hrs light/12 hrs dark

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: 80% Ethanole/20% dest water for induction and acetone for challenge
Concentration / amount:
50 % w/v
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: 80% Ethanole/20% dest water for induction and acetone for challenge
Concentration / amount:
50 % w/v
No. of animals per dose:
20
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Frequency of applications: once a week during three consecutive weeks
- Duration: 6h
- Concentrations: 50 % (w/v)

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 2 weeks after last induction experiment
- Exposure period: 6 h
- Control group: 10 animals
- Concentrations: 50 % (w/v)
- Evaluation (hr after challenge): 24

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Remarks on result:
not measured/tested
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Remarks on result:
not measured/tested
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50 %
No. with + reactions:
4
Total no. in group:
20
Clinical observations:
no observations
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50 %. No with. + reactions: 4.0. Total no. in groups: 20.0. Clinical observations: no observations.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50 %
No. with + reactions:
2
Total no. in group:
20
Clinical observations:
no observations
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50 %. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: no observations.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no observations
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: 10.0. Clinical observations: no observations.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
3
Total no. in group:
10
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: 3.0. Total no. in groups: 10.0. Clinical observations: no observations.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Following primary challenge there were no grades of 1 produced in the test or control animals. the incidence of grade +- responses in the test group (5 of 20) was compared to that of the native control (3 of 10). The incidence and severity of responses in the test group were essentially comparable to those produced by the native control group indicating that sensitization has not been induced.
Executive summary:

Hexagonal boron nitride is not classified as a skin sensitizer.