Registration Dossier
Registration Dossier
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EC number: 700-008-0 | CAS number: 3753-18-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was performed between 20 January 1998 and 31 January 1998.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- UK GLP standards (Schedule 1, Good Laboratory Practice Regulations 1997 (SI 1997/654)). Date of signature: 30/03/98.
Test material
- Reference substance name:
- 4,4'-bis(methoxymethyl)-1,1'-biphenyl
- EC Number:
- 700-008-0
- Cas Number:
- 3753-18-2
- Molecular formula:
- C16 H18 O2
- IUPAC Name:
- 4,4'-bis(methoxymethyl)-1,1'-biphenyl
- Reference substance name:
- 4,4-bis(methoxymethyl)-biphenyl
- IUPAC Name:
- 4,4-bis(methoxymethyl)-biphenyl
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK.
- Age at study initiation: 12 to 16 weeks
- Weight at study initiation: 2.49 to 2.79 kg
- Housing: Suspended metal cages.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 20°C
- Humidity (%): 50 to 65%
- Air changes (per hr): Approximately 15 changes per hour
- Photoperiod (hrs dark / hrs light): controlled by time switch to give 12 hours continuous light followed by 12 hours darkness
IN-LIFE DATES: From: Day of application (Day 0) To: Sacrifice (72 hours after application)
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g moistened with 0.7 ml of distilled water
- Concentration (if solution): not applicable
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.7 ml
- Concentration (if solution): not applicable
- Lot/batch no. (if required): not applicable
- Purity: not applicable - Duration of treatment / exposure:
- Animal 1: Three patches
first patch = 3 minutes exposure
second patch = 1 hour exposure
third patch = 4 hours exposure
Second and third animals:
Patch = 4 hours exposure - Observation period:
- 72 hours
- Number of animals:
- three
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm patches
- % coverage: not stated in report
- Type of wrap if used: a cotton gauze patch secured with a strip of surgical adhesive tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: when patch removed i.e. 3 minutes, 1 hour or 4 hours.
SCORING SYSTEM: Draize, J.H. (1977) "Dermal and eye Toxicity Tests" In: Principles and Procedures for evaluating the toxicity of household Substances, National Academy of Sciences, Washington DC, p 31.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 8 Female
- Time point:
- other: Mean of 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects observed
- Irritation parameter:
- erythema score
- Basis:
- animal: 23 Male
- Time point:
- other: Mean of 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No effects observed
- Irritation parameter:
- erythema score
- Basis:
- animal: 42 Male
- Time point:
- other: Mean of 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No effects observed
- Irritation parameter:
- edema score
- Basis:
- animal: 8 Female
- Time point:
- other: Mean of 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No effects observed
- Irritation parameter:
- edema score
- Basis:
- animal: 23 Male
- Time point:
- other: Mean of 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No effects observed
- Irritation parameter:
- edema score
- Basis:
- animal: 42 Male
- Time point:
- other: Mean of 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No effects observed.
- Irritant / corrosive response data:
- No evidence of skin irritation was noted during the study. No corrosive effects were noted.
- Other effects:
- None described.
Any other information on results incl. tables
No evidence of skin irritation was noted during the study.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material did not meet the criteria for classification as irritant or corrosive according to EU or GHS labelling regulations. No symbol or risk phrase are required.
- Executive summary:
A study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method used followed the recommendations of the OECD Guidelines for Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion" (adopted 17 July 1992) and Method B4 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).
The results may be used as a basis for classification and labelling under Annex VI of Council Directive 67/548/EEC (as adap[ted to technical progress by Commission Directive 93/21/EEC) relating to the classification, packaging and labelling of dangerous substances.
A single 4 -hour, semi-occluded application of the test material to the intact skin of three rabbits produced no evidence of skin irritation. No corrosive effects were noted.
3 -minute and 1 -hour semi-occluded applications of the test material to the intact skin of one rabbit produced no corrosive effects.
The test material did not meet the criteria for classification as irritant or corrosive according to EU or GHS labelling regulations. No symbol or risk phrase are required.
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