Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 247-570-9 | CAS number: 26266-63-7
Toxicological information
Skin sensitisation
Currently viewing:
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:
- other: Well conducted study according to recognised OECD test methods.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study undertaken prior to the introduction of the LLNA method
Test material
- Reference substance name:
- Tetrahydrophthalic anhydride
- EC Number:
- 247-570-9
- EC Name:
- Tetrahydrophthalic anhydride
- Cas Number:
- 26266-63-7
- Molecular formula:
- C8H8O3
- IUPAC Name:
- tetrahydro-2-benzofuran-1,3-dione
Constituent 1
- Specific details on test material used for the study:
- - Lot/batch No.: Verformung der Nachtschicht vom 02./03.03.1988
- Storage condition of test material: Protected from light and humidity
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: F. Winkelmann, D-4799 Borchen, Germany
- Weight at study initiation: 271 - 339 g
- Housing: Up to 5 animals / cage in Makrolon Type IV cages
- Diet (e.g. ad libitum): G4 guinea pig diet, Ssniff spezialfutter GmbH D-4770 Soest, Germany, ad libitum
- Water (e.g. ad libitum):Tap water, ad libitum
- Acclimation period: 4 - 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 21 deg C
- Humidity (%): 55 - 65 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hour light / 12 hour dark
IN-LIFE DATES: From: 1988-04-12 To: 1988-05-06
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- maize oil
- Concentration / amount:
- Induction, injection: 0.5% in maize oil and o.5% in FCA emulsion
Induction, epicutaneous: 100%
Challenge, epicutaneous: 100%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- maize oil
- Concentration / amount:
- Induction, injection: 0.5% in maize oil and o.5% in FCA emulsion
Induction, epicutaneous: 100%
Challenge, epicutaneous: 100%
- No. of animals per dose:
- Test 20
Control: 10 - Details on study design:
- RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: Single intradermal injection on Day 1; 48 hour epicutaneous exposure over injection sites one week later
- Test groups:
Induction, injection - 2 x 0.1 mL FCA emulsion + 2 x 0.1 mL 0.5% substance in maize oil + 2 x 0.1 mL 0.5% substance in FCA emulsion
Induction, epicutaneous - 100% substance spread over 2 x 4 cm area
- Control group:
Induction, injection - 2 x 0.1 mL FCA emulsion + 2 x 0.1 mL maize oil + 2 x 0.1 mL maize oil in FCA emulsion
Induction, epicutaneous - Maize oil spread over 2 x 4 cm area
- Site: Scapular region
- Frequency of applications: 1 x injection + 1 x epicutaneous
- Duration: Single intradermal injection on Day 1; 48 hour epicutaneous exposure over injection sites one week later
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 2 weeks after end of induction
- Exposure period: 24 hours
- Test groups: 100% substance spread over 2 x 2 cm area
- Control group: 100% substance spread over 2 x 2 cm area
- Site: left flank
- Evaluation (hr after challenge): 24 and 48 hours after end of challenge exposure - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 17
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 17.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 17
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 17.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Group:
- positive control
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- Tetrahydrophthalic anhydride causes delayed dermal sensitisation in the guinea pig maximisation test of Magnusson and Kligman
- Executive summary:
Dermal sensitisation has been investigated in a maximisation test according to OECD test methods. A marked sensitisation response was observed to tetrahydrophthalic anhydride following a period of induction exposure.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
