Registration Dossier
Registration Dossier
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EC number: 411-280-2 | CAS number: 74091-64-8 MR-8A; MR-N2; NBDI
Skin sensitisation
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:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: US EPA Pesticide Assessment Guidelines, Subdivision F, Part 81-6 (Magnusson-Kligman)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was performed before the LLNA was validated.
Test material
- Reference substance name:
- 2,5-bis-isocyanatomethyl-bicyclo[2.2.1]heptane
- EC Number:
- 411-280-2
- EC Name:
- 2,5-bis-isocyanatomethyl-bicyclo[2.2.1]heptane
- Cas Number:
- 74091-64-8
- Molecular formula:
- C11H14N2O2
- IUPAC Name:
- (1R,2R,4R,5R)-2,5-bis(isocyanatomethyl)bicyclo[2.2.1]heptane; (1R,2S,4R,5S)-2,5-bis(isocyanatomethyl)bicyclo[2.2.1]heptane; (1S,2R,4S,5R)-2,5-bis(isocyanatomethyl)bicyclo[2.2.1]heptane; (1S,2S,4S,5S)-2,5-bis(isocyanatomethyl)bicyclo[2.2.1]heptane; bis((1r,2R,4s,6S)-2,6-bis(isocyanatomethyl)bicyclo[2.2.1]heptane); bis((1s,2R,4r,6S)-2,6-bis(isocyanatomethyl)bicyclo[2.2.1]heptane)
- Details on test material:
- - Name of test material (as cited in study report): NBDI
- Physical state: liquid
Constituent 1
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 chemical
- 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 chemical
- 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:
- other: Category 1A in accordance with CLP Regulation EC No 1272/2008
- 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.
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