Registration Dossier
Registration Dossier
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EC number: 201-604-9 | CAS number: 85-42-7
Endpoint summary
Administrative data
Description of key information
Skin sensitisation: sensitising
Respiratory sensitisation: sensitising
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study undertaken prior to the introduction of the LLNA (OECD TG 429 originally adopted April 2002)
- Specific details on test material used for the study:
- - Manufacturing date: 22 Aug 1988
- Storage condition of test material: Protected from light and humidity - 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: 303 - 359 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: 1988-09-20 To: 1988-10-14 - 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% - 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:
- 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
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 19
- 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: 19.0. Total no. in groups: 20.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 16
- 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: 16.0. 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
- Interpretation of results:
- sensitising
- Conclusions:
- Hexahydrophthalic 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 hexahydrophthalic anhydride following a period of induction exposure.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Dermal sensitisation has been investigated in a maximisation test according to OECD test methods. A marked sensitisation response was observed to hexahydrophathic anhydride following a period of induction exposure
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Allergic reactions of the skin and allergic respiratory reactions are known effects of occupational exposure to cyclic acid anhydrides (Concise International Chemical Assessment Document 75 - Cyclic Acid Anhydrides: Human Health Aspects,World Health Organization, 2009).
Justification for classification or non-classification
Classification, Labelling, and Packaging
Regulation (EC) No 1272/2008
The available experimental test
data are reliable and suitable for classification purposes under
Regulation (EC) No 1272/2008. Allergic reactions of the skin and
allergic respiratory reactions are known effects of occupational
exposure to cyclic acid anhydrides (Concise International Chemical
Assessment Document 75 - Cyclic Acid Anhydrides: Human Health
Aspects,World Health Organization, 2009). This is reflected in current
classification and labelling of the substance.
Based on available data on sensitisation, the test item is to be
classified as Skin Sens. 1, H317 and as Resp. Sens. 1, H334 according to
Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in
Regulation (EU) No 2017/776.
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