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EC number: 203-740-4 | CAS number: 110-15-6
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- Ecotoxicological Summary
- Aquatic toxicity
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- Toxicological Summary
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- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
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- Additional toxicological data

Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 7 July - 1 December 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study according to GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Bernsteinsaure = Succinic acid
- IUPAC Name:
- Bernsteinsaure = Succinic acid
- Reference substance name:
- 1,4-butane-di-carbonic-acid
- IUPAC Name:
- 1,4-butane-di-carbonic-acid
- Reference substance name:
- Succinic acid
- EC Number:
- 203-740-4
- EC Name:
- Succinic acid
- Cas Number:
- 110-15-6
- Molecular formula:
- C4H6O4
- IUPAC Name:
- succinic acid
- Details on test material:
- - Name of test material (as cited in study report): Bernsteinsaure = succinic acid
- Physical state: white crystalline powder
- Analytical purity: 99.5%
- Impurities (identity and concentrations): water
- Purity test date: no details
- Lot/batch No.: SLMB 112
- Expiration date of the lot/batch: December 1999
- Stability under test conditions: stable for duration of study
- Storage condition of test material: in refrigerator in dark
- Other: Density at 20°C = 1.56 g/cm3. pH 2.7 (1% w/v dispersion in water)
Constituent 1
Constituent 2
Constituent 3
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga
- Age at study initiation: Not stated
- Weight at study initiation: 2.9 kg
- Housing:Individual metal wire caging
- Diet (e.g. ad libitum): Altromin 2023 ad libitum
- Water (e.g. ad libitum): tap water via automatic watering system - ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Mean 20°C
- Humidity (%): Mean 63 %
- Air changes (per hr): 12/h
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 20 September 1999 To: 12 October 1999
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 mL (equivalent to a weight of 100 mg)
- Duration of treatment / exposure:
- Eye held closed to prevent immediate ejection of dose. Treated eye was rinsed with water 24 hours after instillation to remove any residual material.
- Observation period (in vivo):
- 1, 24, 48 and 72 hours after instillation and then 6, 8, 10, 13, 15 and 21 days after dosing
- Number of animals or in vitro replicates:
- One female
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): treated eye rinsed 24 hours after instillation
SCORING SYSTEM: Standard modified Draize ocular assessment scale
TOOL USED TO ASSESS SCORE: otoscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24-72 h and day 21
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- reactions persisted to termination on day 21
- Remarks on result:
- other: reactions persisted to termination on day 21
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24-72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- other: corneal reactions persisted to termination on day 21, it is assumed that iridial reactions would also persist
- Remarks on result:
- other: It was not possible to provide a score for iridial change recorded due to extensive corneal opacity precluding assessment or ophthalmological examination of the iris, it is assumed that a maximum score of 2 would have been assigned.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24-72 h and to day 21
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: Although reactions showed some amelioration over the three week observation period, some conjunctivitis remained at termination
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24-72 h and up to day 21
- Score:
- 3.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 days
- Remarks on result:
- other: marked chemosis persisted to 72 h after instillation but reactions lessened over the first week and the conjunctival swelling had overtly resolved by day 15
- Irritant / corrosive response data:
- Only one rabbit was treated. Corneal opacification affected the entire corneal surface from Day 1 to Day 21 with no resolution or improvement. The severity of the corneal obfuscation precluded any assessment of iris response or iridial changes. Conjunctival reactions include a diffuse beefy red discoloration that persisted for 6 days and gradually reduced in severity but did not fully resolve before termination on day 21. The degree of conjunctival swelling, initially severe, improved slowly and had resolved fully by day 15
- Other effects:
- At 48 and 72 hours the region located dorsally to the treated eye was also swollen
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- Instillation of succinic acid to one rabbit eye resulted in severe and persistent irritant reaction. According to these results and to the Directive 93/21/EEC, the test substance poses a "risk of serious damage to eyes".
- Executive summary:
In a single rabbit eye irritation test, conducted in accordance with OECD and EU test guidelines, persistent reactions were observed that failed to fully resolve within 21 days of instillation.
According to these results and to the Directive 93/21/EEC, the test substance poses a "risk of serious damage to eyes".
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