Registration Dossier
Registration Dossier
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EC number: 212-091-6 | CAS number: 762-04-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
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
Test material
- Reference substance name:
- Diethyl phosphonate
- EC Number:
- 212-091-6
- EC Name:
- Diethyl phosphonate
- Cas Number:
- 762-04-9
- Molecular formula:
- C4H11O3P
- IUPAC Name:
- diethyl phosphonate
- Test material form:
- other: liquid
- Details on test material:
- content 98.86 %
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Bor:DHPW
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source:
- Age at study initiation: 7 weeks
- Weight at study initiation: 321-378 g
- Housing: in groups of 5 during acclimation
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 50
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 /12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- propylene glycol
- Concentration / amount:
- Induction 5 % and 100 %
1. Challenge: 50 and 25 %
2. Challenge: 12 and 3 %
Challengeopen allclose all
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- propylene glycol
- Concentration / amount:
- Induction 5 % and 100 %
1. Challenge: 50 and 25 %
2. Challenge: 12 and 3 %
- No. of animals per dose:
- test groups of 20 animals control groups of 10 animals
- Details on study design:
- according to the respective guideline
- Challenge controls:
- no data
- Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- no data
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 15
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 72.0. Group: test group. Dose level: 50 %. No with. + reactions: 15.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 12 %
- No. with + reactions:
- 8
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 72.0. Group: test group. Dose level: 12 %. No with. + reactions: 8.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 50 %
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 50 %. No with. + reactions: 1.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 12%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 72.0. Group: negative control. Dose level: 12%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 9
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 72.0. Group: test group. Dose level: 25 %. No with. + reactions: 9.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 3 %
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 72.0. Group: test group. Dose level: 3 %. No with. + reactions: 5.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 25 %. No with. + reactions: 1.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 3 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 72.0. Group: negative control. Dose level: 3 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
After the first challenge with 50 %: 75 % of the test animals and 20 % of the control animals showed reactions
After the second challenge with 12 %: 40 % of the test animals but no control animal showed reactions
After the first challenge with 25 % 45 % of the test animals and 10 % of the control animals showed reactions
After the second challenge with 3 %: 25 % of the test animals but no control animal showed reactions
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Executive summary:
Diethylphosphit was tested for skin sensitization property using the Guinea pig maximization test as described in OECD TG and under GLP conditions. Intradermal induction concentration was a 5 % solution , topical induction was performed with a 100 % solution of the test item. First challenges were performed with 50% and 25 % solutions and second challenge with 12 % and 3 % solutions, respectively. The solvent was propylene glycol.
After the first challenge with 50 %: 75 % of the test animals and 20 % of the control animals showed reactions. After the second challenge with 12 %: 40 % of the test animals but no control animal showed reactions
After the first challenge with 25 % 45 % of the test animals and 10 % of the control animals showed reactions. After the second challenge with 3 %: 25 % of the test animals but no control animal showed reactions
Thus, under the conditions of this test, taking into account the potency categorisation given in ECHA Guidance Document R 8 (Version 2), R8 -10 (2010) Diethylphosphit is a moderate skim-sensitizer.
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