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EC number: 201-803-0 | CAS number: 88-14-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
Data source
Referenceopen allclose all
- Reference Type:
- other: authoritative database
- Title:
- Hazardous Substances Data Bank (HSDB) for Benzotriazole
- Author:
- U.S National Library of Medicine
- Year:
- 2 013
- Bibliographic source:
- Hazardous Substances Data Bank (HSDB), U.S National Library of Medicine 2013
- Reference Type:
- secondary source
- Title:
- Report on skin sensitization (contact allergenic) effect on guinea pigs of TK11’237 with cover letter dated 072893
- Author:
- NTRL
- Year:
- 1 993
- Bibliographic source:
- NTRL OTS0538207 dated 072893 1993
Materials and methods
Test guideline
- Qualifier:
- according to
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- To assess skin sensitization potential of Benzotriazole on Pirbright white guinea Pig’s skin.
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Not specified
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- solid
- Details on test material:
- IUPAC :Benzotriazole
CAS :95-14-7
EC No: 202-394-1
InChI:1S/C6H5N3/c1-2-4-6-5(3-1)7-9-8-6/h1-4H,(H,7,8,9)
Smiles:c12c(nn[nH]1)cccc2
substance type: organic
physical state:solid
- Specific details on test material used for the study:
- IUPAC :Benzotriazole
CAS :95-14-7
EC No: 202-394-1
InChI:1S/C6H5N3/c1-2-4-6-5(3-1)7-9-8-6/h1-4H,(H,7,8,9)
Smiles:c12c(nn[nH]1)cccc2
substance type: organic
physical state:solid
Molecular weight:119.1265 g/mol
Molecular formula:C6H5N3
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright white
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: same Breeded in the laboratory premises.
- Age at study initiation: approx 10 weeks old
- Weight at study initiation: 276-416 gms
- Housing: individually in Macrolon cages type 3.
- Diet (e.g. ad libitum): guinea pig pallets NAFAG No.830, Gossau SG ad libitum supplemented with fresh carrots.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 11 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±1°C
- Humidity (%): 50±10%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 14 hrs light cycle
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- Concentration-0.1%
Amount-0.1 ml - Day(s)/duration:
- 3 weeks
- Adequacy of induction:
- not specified
Challengeopen allclose all
- No.:
- #1
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.1 ml in 0.1% saline
- Day(s)/duration:
- 1 day
- Adequacy of challenge:
- not specified
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline
- Concentration / amount:
- 30% in vaseline
- Day(s)/duration:
- 1 day
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- Test groups: 20
- Control group: 20 - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period: No data
- Test groups: 20
- Control group: 20
- Site: flank and back
- Frequency of applications: consecutive days
- Duration: 3 weeks
- Concentrations: 0.1 ml / 0.1%
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 1 days
- Exposure period: 24 hrs
- Test groups: 20
- Control group:20
- Site: flank
- Concentrations: 0.1 ml / 0.1 %
- Evaluation (hr after challenge): 24 hrs
C. RECHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 1
- Exposure period: 24 hrs
- Test groups: 20
- Control group: 20
- Site: No data
- Concentrations: 30% in vesline
- Evaluation (hr after challenge): 24 hrs
OTHER: epicuteneous application under occlusion. - Challenge controls:
- Not specified
- Positive control substance(s):
- yes
- Remarks:
- physiological saline
Study design: in vivo (LLNA)
- Statistics:
- Fisher's test,( p>0.01)
Results and discussion
- Positive control results:
- 2 out of 20 guine pigs were showing reaction to control.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test group
- Dose level:
- 0.1 ml in 0.1% saline
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test group
- Dose level:
- 30% in vaseline
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no skin reaction observed
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: Not sensitizing
- Conclusions:
- Benzotriazole was considered to be non sensitizing after introducing it inta dermally as induction dose 0.1 ml 0.1% and challenge dose after 14 days of resting period , second challenge was introduced as epicuteneous application 30% in vaseline under occlusion no positive reaction was noted.
- Executive summary:
Benzotriazole was evaluated for dermal sensitization in the optimization test. Pirbright white guinea pigs (10/sex/group) were administered 10 consecutive 0.1 ml intracutaneous injections of 0.1% in physiological saline or the vehicle alone. Induction was initiated with an intracutaneous injection both into the shaved flank and into the back, followed by a single injection into the back every other day, Complete Bacto Adjuvant supplemented the 0.1% solution (1:1, vehicle/adjuvant) in second and third weeks of the induction period. After a 14-day resting period, challenge with 0.1 ml intracutaneous injections of 0.1% in saline into the flanks of control and inducted guinea pigs was given. Injection sites were each inspected 24 hours after induction and challenge. No significant increase in number of positive reactions was noted among inducted guinea pigs. (3/20 positive reactions) relative to controls (2/20 positive reactions). A second challenge, consisting of a subirritant epicutaneous application (30% in vaseline) under occlusive wrap for 24 hours, followed the first by 10 days. Reactions (based on the Draize irritation index) to epicutaneous challenge, evaluated 24 hours later, also failed to demonstrate sensitization in inducted animals (0/20 positive reactions)
No positive reactions were noted.
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