Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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: 204-112-2 | CAS number: 115-86-6
Skin sensitisation
Administrative data
- 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:
- other: conforms to current guideline and GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- This Guinea pig maximization test was performed in 2001, i.e. before the LLNA became the standard test for assessment.
Test material
- Reference substance name:
- Triphenyl phosphate
- EC Number:
- 204-112-2
- EC Name:
- Triphenyl phosphate
- Cas Number:
- 115-86-6
- Molecular formula:
- C18H15O4P
- IUPAC Name:
- triphenyl phosphate
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): TPP
- Physical state: White granular solid
- Lot/batch No.: F21022
- Storage condition of test material: room temperature in the dark
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: supplied by David Hall Limited UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 345 - 410 g
- Housing: singly or in pairs in solid floor polyproylene cages furnished with woodflakes
- Diet (e.g. ad libitum): Free access to guinea pig FD1 diet
- Water (e.g. ad libitum): Free access to tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23 deg C
- Humidity (%): 30 to 70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours/light
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- arachis oil
- Concentration / amount:
- intradermal induction: 5%
topical induction: 75 %
topical challenge: 75 % and 50 %
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- arachis oil
- Concentration / amount:
- intradermal induction: 5%
topical induction: 75 %
topical challenge: 75 % and 50 %
- No. of animals per dose:
- 10 test and 5 control
- Details on study design:
- 1st application; intradermal induction:
Shortly before treatment the hair was removed from an area approx. 40 x 60 mm on the sholder region of each animal. A row of three injections was made:
a) Freud's Complete Adjuvant plus destilled water in a ration 1:1
b) 5 % w/w TPP in arachis oil
c) a 5% w/w formulation of TPP in a 1:1 preparation with Freud's Complete Adjuvant plus destiled water
Approx. 24 and 48 hours after intradermal induction the degree of erythema at the test material injection site was evaluated.
2nd application; topical induction:
On day 7 the same area was clipped again and treated with topical application of the test material (75 % w/w in arachis oil; occlusive epicutaneous)
3rd application topical Challenge:
On day 21 an area of approx. 50 x 70 mm on both flancs of each animal was ciplled free of hair and topicallytreated with 75 % and 50% w/w TPP in arachis oil (occlusive epicutaneous) - Positive control substance(s):
- yes
- Remarks:
- 2-Mercaptobenothiazole
Results and discussion
- Positive control results:
- The positive control gave the expected positive results (see results table)
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 50% and 25% in acetone:PEG 400 (70:30)
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- no data
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- summary of 6 tests (9-10 positive reactions/10 animals)
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 and 75 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no data
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 and 75 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no data
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50 and 75%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50 and 75%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 50 and 25% 2-Mercaptobenzothiazole
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- summary of 6 tests (9-10 positive reactions/10 animals)
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- not sensitizing
- Executive summary:
A study was performed to assess the contact sensitisation potential of TPP in guinea pigs according to OECD guidelines study 406. Ten test and five control animals were used for the study. Two phases were involved in the main study; an induction of a response by intradermal injection and topical application and a topical challenge of that response. Based on sighting tests, the concentrations of TPP for the induction and challenge phases were selected as:
Intradermal induction: 5%w/w in arachis oil; Topical Induction: 75%w/w in arachis oil; Topical challenge 75 and 50%w/w in arachis oil. The results showed that TPP produced a 0% (0/10) sensisitisation rate and classified as a non-sensitiser to guinea pig skin.
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.
