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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:
March 6, 1992 - February 9, 1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: US EPA Pesticide Assessment Guidelines, Subdivision F, Part 81-6 (Magnusson-Kligman)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes (incl. certificate)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The study was performed before the LLNA was validated.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): NBDI
- Physical state: liquid

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen
- Age at study initiation: no data
- Weight at study initiation:
test group (22): 377 +/- 31.84 g
vehicle group (22): 368.2 +/- 18.25 g
- Housing: guinea pigs per cage: 1-4
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2 degrees Celsius
- Humidity (%): 45-65%
- Air changes (per hr): 12-15 times/hour
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: August 4, 1992 To: September 25, 1992

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: vaseline (challenge) and paraffin oil (induction)
Concentration / amount:
Concentration used at induction: a) 0,2 % in paraffin oil (injection) b) 1.0 % in vaseline (patch) Concentration used for each challenge: 0,01 % in vaseline (patch)
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: vaseline (challenge) and paraffin oil (induction)
Concentration / amount:
Concentration used at induction: a) 0,2 % in paraffin oil (injection) b) 1.0 % in vaseline (patch) Concentration used for each challenge: 0,01 % in vaseline (patch)
No. of animals per dose:
Number of animals in test group: 22
Number of animals in control: 22
Details on study design:
RANGE FINDING TESTS:
1) To determine the concentration which causes only slight irritation for the use in the intradermal exposure of the main study:
Intradermal injection with 0.2, 1, 5 and 10% dissolved in paraffin oil
2) To determine the concentration which causes no irritation and the highest
concentration which causes only mild irritation
for the use in the 2 dermal applications of the main study:
Two times 10 animals received topical applications at concentrations of:
0.005, 0.01, 0.05, 0.2, 1, 4, 10 and 25% in vaseline

MAIN STUDY
Test animals: 22
Control animals: 22

A. INDUCTION EXPOSURE
- No. of exposures: 2

1)Intradermal injections on day 0:
- Concentration: 0.2% in paraffin oil
- Site: r + l shoulder
Three pairs of intradermal injections:
1) 0.1 mL: FCA
2) 0.1 mL: 0.2% of the substance
3) 0.1 mL: 0.2% of the substance + FCA

2)Topical application on day 7:
-Concentration: 1% in vaseline
-Exposure period: 48 hours (occlusive)

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: day 21 (14 days after last induction)
- Exposure period: 24 hours (occlusive)
- Site: left flank
- Concentrations: 0.01% in vaseline
- Evaluation (hr after challenge):
24 hours after patch removal (day 23) and on day 24
Positive control substance(s):
yes
Remarks:
DNCB

Results and discussion

Positive control results:
Positive in all animals

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0.01%
No. with + reactions:
7
Total no. in group:
21
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.01%. No with. + reactions: 7.0. Total no. in groups: 21.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
0.01%
No. with + reactions:
16
Total no. in group:
21
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.01%. No with. + reactions: 16.0. Total no. in groups: 21.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
N/A
No. with + reactions:
0
Total no. in group:
22
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: N/A. No with. + reactions: 0.0. Total no. in groups: 22.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
N/A
No. with + reactions:
1
Total no. in group:
22
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: N/A. No with. + reactions: 1.0. Total no. in groups: 22.0.

Any other information on results incl. tables

In the preliminary test it was determined that the dose used for the challenge, does not show any irritation. This dose will therefore be used for deriving the DNEL acute - dermal, local effects.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
Based on the results of a guinea pig maximisation test performed according to OECD guideline 406, the substance was considered to have skin sensitising properties.