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Diss Factsheets

Administrative data

Description of key information

No skin sensitisation study with dichromium nitride is available. However, based on the information available from a skin sensitisation study (OECD 406; GLP) with basic chromium (III) sulphate , it was concluded using a category read-across concept that dichromium nitride is not sensitising either. The approach for read-across is described in detail in the document attached in IUCLID section 13.

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
An appropriate Buehler test is available which would not justify conducting an additional LLNA due to animal welfare.
Species:
guinea pig
Strain:
Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River
- Age at study initiation: 5-6 weeks
- Weight at study initiation: 331-397 g
- Housing: groups of two or five
- Diet: ad libitum
- Water: ad libitum)
- Acclimation period: five days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 40-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 06/06/2006 To: 06/07/2006
Route:
epicutaneous, semiocclusive
Vehicle:
physiological saline
Concentration / amount:
80% was used for induction and challenge
Route:
epicutaneous, semiocclusive
Vehicle:
physiological saline
Concentration / amount:
80% was used for induction and challenge
No. of animals per dose:
Ten control animals; 20 test animals
Details on study design:
RANGE FINDING TESTS:

No signs of irritation were seen at concentrations of up to 80% (the highest tested) (6-hour occlusive application)


MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: three
- Exposure period: six hours
- Test groups: 20 animals
- Control group: 10 animals
- Site: left flank
- Frequency of applications: once per week
- Duration: six hours
- Concentrations: 50%


B. CHALLENGE EXPOSURE
- No. of exposures: one
- Day(s) of challenge: two weeks following the final induction
- Exposure period: 6 hours
- Test groups: 20 animals
- Control group: 10 animals
- Site: back and right flank
- Concentrations: 0% and 80%
- Evaluation (hr after challenge): 24 and 48 hours
Challenge controls:
Test and control animals were challenged with 80% test material (in physiological saline) and vehicle alone.
Positive control substance(s):
yes
Remarks:
alpha hexyl cinnamic aldehyde
Positive control results:
Challenge with 20% positive control (in saline) resulted in dermal effects in 9/20 animals (45% response)
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
vehicle
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: vehicle. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
vehicle
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: vehicle. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
80%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 80%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
80%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 80%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
vehicle
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: negative control. Dose level: vehicle. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
vehicle
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: negative control. Dose level: vehicle. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
80%
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: negative control. Dose level: 80%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
80%
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: negative control. Dose level: 80%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.

Dermal reactions during the induction phase were limited to one animal following the second and third exposures (Grade 1 erythema, desquamation). Similar findings were not seen in this animal following challenge.

Interpretation of results:
GHS criteria not met
Remarks:
(based on the results of this study)
Conclusions:
No evidence of sensitisation was seen under the conditions of this study.
Executive summary:

The potential of the test material (a mixture of basic chromium sulphate, sodium sulphate and water) to induce delayed contact hypersensitivity (skin sensitisation) was investigated in a three-induction Buehler study using female Hartley guinea pigs. The concentrations of the test material used for induction and challenge applications were based on the results of a preliminary study. The results of an acceptable positive control study are also reported, confirming the sensitivity of the assay. Induction was performed on 20 test animals using 6 -hour semi-occlusive application of 0.5 ml test material (80% in physiological saline); a total of three applications were made over a three-week period. Ten control animals were similarly treated, using vehicle. Two weeks following the final induction application, all test and control animals were challenged using a 6- hour semi-occlusive application of the test material (80%). Dermal reactions were assessed at 24 and 48 hours following patch removal. No dermal reactions were seen in test or control animals. No evidence of sensitisation was seen under the conditions of this study.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Skin sensitisation

One reliable animal study described in Vohr (2006) (OECD 406; GLP compliant) is considered to be reliable without restrictions. The substance was determined not to be a skin sensitiser.

Furthermore, the release of chromium from dichromium nitride into artificial sweat was investigated in a bioaccessibility study. Since the dissolution of chromium was very low (< 0.0071%) it can be concluded that the potential for dichromium nitride to cause sensitisation due to dissolved chromium (III) is highly unlikely.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Skin sensitisation

The substance does not possess a skin sensitisation potential and does not require classification as skin sensitiser according to Regulation (EC) No 1272/2008 and subsequent adaptations.