Registration Dossier
Registration Dossier
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EC number: 226-641-8 | CAS number: 5444-75-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24 Jan - 25 Feb 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Vertberate study predates requirement to test in-vitro before vertebrate studies
Test material
- Reference substance name:
- 2-ethylhexyl benzoate
- EC Number:
- 226-641-8
- EC Name:
- 2-ethylhexyl benzoate
- Cas Number:
- 5444-75-7
- Molecular formula:
- C15H22O2
- IUPAC Name:
- 2-ethylhexyl benzoate
- Details on test material:
- - Name of test material (as cited in study report): 2-Ethylhexyl benzoate
- Physical state: clear colourless liquid
- Analytical purity: 99.734%
- Impurities (identity and concentrations): 2-Ethyl-4-methyl-1-pentyl benzoate 0.209%, C8 benzoate 0.023%, 2-Ethylhexyl phthalate 0.004%, unknown impurities 0.03%
- Lot/batch No.: 9915-133-2
- Sample ID: 9915-140-1
- Expiration date of the lot/batch: 2000-12-04
- Storage condition of test material: room temperature in light, in brown glass bottle
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: D. Hall (Newchurch, Staffs, UK)
- Age at study initiation: 4-7 weeks
- Weight at study initiation: 362-435 g
- Housing: the animals were housed in groups of five in suspended metal cages with wire mesh floors.
- Diet: vitamin C enriched guinea-pig diet (Harlan Teklad 9600 FD2 SQC), ad libitum. In addition, hay was given thrice weekly.
- Water: drinking water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-20
- Humidity (%): 38-58
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Alembicol D
- Concentration / amount:
- Preliminary study:
Intradermal: 0.1-10%; epicutaneous: 25-100%
Main study:
Induction:
Intradermal: 7.5%; epicutaneous: 100%
Challenge:
37.5 and 75%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Alembicol D
- Concentration / amount:
- Preliminary study:
Intradermal: 0.1-10%; epicutaneous: 25-100%
Main study:
Induction:
Intradermal: 7.5%; epicutaneous: 100%
Challenge:
37.5 and 75%
- No. of animals per dose:
- Preliminary study
6
Main study
5 (controls), 10 (in test group) - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)
- Test groups:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA/water
Injection 2: test substance in Alembicol D
Injection 3: test substance in a 1:1 mixture (v/v) FCA/water
Epicutaneous: test substance
- Control group:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA/water
Injection 2: Alembicol D
Injection 3: Alembicol D in a 1:1 mixture (v/v) FCA/water
Epicutaneous: Alembicol D
- Site: flank
- Frequency of applications: every 7 days
- Duration: Day 0-8
- Concentrations: intradermal 7.5%, epicutaneous 100%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 20
- Exposure period: 24 h
- Test groups: test substance
- Control group: test substance
- Site: left flank
- Concentrations: 37.5 and 75% (v/v)
- Evaluation (hr after challenge): 48 and 72 h
OTHER:
The preliminary investigations indicated that the neat test substance applied topically did not produce skin irritation. Therefore, six days after the injections, the injection site was clipped and shaved free of hair and the site was pre-treated by gentle rubbing with 0.5 mL per site of 10% (w/w) sodium lauryl sulphate in petrolatum. - Challenge controls:
- The control group is actually a challenge control.
- Positive control substance(s):
- yes
- Remarks:
- hexyl cinnamic aldehyde (induction: 10% intradermal; epicutaneous 100%; challenge: 100%)
Results and discussion
- Positive control results:
- The positive control substance (10% hexyl cinnamic aldehyde in Alembicol D (intradermal), 50 and 100% (challenge)) induced positive reactions in 9/10 animals (90%), thus confirming the sensitivity and reliability of the experimental technique.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0% (induction); 37.5 and 75% (challenge)
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0% (induction); 37.5 and 75% (challenge). No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 7.5 and 100% (induction: intradermal and epicutaneous); 37.5 and 75% (challenge)
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- slight erythema at application site (75% of the test material) in 1/10 animals
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 7.5 and 100% (induction: intradermal and epicutaneous); 37.5 and 75% (challenge). No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: slight erythema at application site (75% of the test material) in 1/10 animals.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0% (induction); 37.5 and 75% (challenge)
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0% (induction); 37.5 and 75% (challenge). No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 7.5 and 100% (induction: intradermal and epicutaneous); 37.5 and 75% (challenge)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 7.5 and 100% (induction: intradermal and epicutaneous); 37.5 and 75% (challenge). No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
No signs of ill health or toxicity were observed.
After intradermal injections with FCA necrosis was recorded in test and control animals. Slight irritation was seen in test animals receiving intradermal 7.5% of the test substance in Alembicol D and in control animals.
After topical application, slight erythema was observed in 5/10 animals and well defined erythema in 4/10 animals; no erythema was seen in the control animals. After challenge, slight erythema was noted for one test animal at the 24 h reading only. The reaction was considered to be a background irritation.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- CLP: not classified
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