Registration Dossier
Registration Dossier
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EC number: 904-155-3 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Remarks:
- The tested substance (TMP) is a main component of the registered multi-constituent substance HB TMP.
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: scientifically acceptable and sufficiently documented
- Justification for type of information:
- This endpoint study record is part of a Weight of Evidence approach comprising both inconclusive in vitro studies on the registered substance HB TMP as well as a read-across to in vivo rabbit studies on two of the three main components of the registered mulit-constituent substance.
REPORTING FORMAT FOR THE ANALOGUE APPROACH
[Please provide information for all of the points below. Indicate if further information is included as attachment to the same record, or elsewhere in the dataset (insert links in 'Cross-reference' table)]
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The main components of HB TMP is Di-TMP (2,2'-[oxybis(methylene)]bis[2-ethylpropane-1,3-diol], CAS: 23235-61-2) >20 - <70%, TMF (2,2'-[methylenebis(oxymethylene)]bis[2-ethylpropane-1,3-diol], CAS: 93983-16-5) >15 - <40% and TMP (2-ethyl-2-(hydroxymethyl)propane-1,3-diol CAS: 77-99-6) >2 - <30%, it is therefore considered relevant to include the available information on two of the main components of HB TMP.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
See information provided in the Test material section of the source and target records.
3. ANALOGUE APPROACH JUSTIFICATION
Taking the overall information together, the conclusive studies on HB TMP, TMP and Di-TMP as well as the lack of structural alerts for eye irritation for the read-across substance TMF, it is unlikely that HB TMP exhibits any potential to cause eye irritation. Considering also the two inconclusive in vitro eye irritation studies on HB TMP, applying the method presented in OECD Guideline on Defined Approaches for Serious Eye Damage / Eye Irritation and also the precautionary principle, the Weight of Evidence stipulates HB TMP substance to be classified as Eye irritation Category 2.
4. DATA MATRIX
See related endpoint study records.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
- Principles of method if other than guideline:
- 2 animals, dose 50 mg/animal into the conjunctival sac, postexposure period 7 days.
- GLP compliance:
- no
Test material
- Reference substance name:
- Propylidynetrimethanol
- EC Number:
- 201-074-9
- EC Name:
- Propylidynetrimethanol
- Cas Number:
- 77-99-6
- Molecular formula:
- C6H14O3
- IUPAC Name:
- 2-ethyl-2-(hydroxymethyl)propane-1,3-diol
- Details on test material:
- no data
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- no data
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the other eye of each of the 2 rabbits
- Amount / concentration applied:
- amount: 50 mg
- Duration of treatment / exposure:
- 7 days
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- no data
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 0 h
- Score:
- >= 0 - 1
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1, 2 and 7 d
- Score:
- 0
- Reversibility:
- other: score = 0 at any time point
- Other effects:
- no data
Any other information on results incl. tables
no data
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Executive summary:
A dose of 50 mg/animal was applied into the conjunctival sac of one eye of each of 2 rabbits,
postexposure observation period 7 days. Trimethylolpropane is not irritating (Bayer AG 1979)
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