Registration Dossier
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EC number: 224-832-0 | CAS number: 4511-42-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
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- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Endpoint summary
Administrative data
Description of key information
L-dilactide (>99.5 %) was tested negative for acute dermal irritating properties according to OECD 404. The substance caused reversible eye irritating effects in an acute eye irritation/corrosion study in rabbits according to OECD 405.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1998-06-22 to 1998-07-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to OECD guideline 404
- Qualifier:
- according to
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Qualifier:
- according to
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals and environmental conditions:
- Upon arrival, the rabbits were checked for overt signs of ill health and anomalies. Test animals were females, young adult and were quarantined 54 or 55 days upon arrival. At the start of the study, body weight was 3060-3405 g. Animals were housed individually in stainless steel cages with perforated floor under a 12h light/12h dark cycle at 20 ± 3 °C and 50-76 % humidity (upper limit higher than 70 %, because of wet cleaning of the animal room and/or meteorological circumstances; the 76 % peak occurred for one hour at most); ventilation was ca 10 air changes/hour. Animals were fed standard laboratory rabbit diet ad libitum. Each batch of this diet is analyzed by the supplier (SDS Special Diets services, Whitham, England) for the nutrients and contaminants and the results are available upon request). Tap water (N.V. Waterleidingbedrijf Midden-Nederland) was available ad libitum. Results of routine physical, chemical and microbiological examination of drinking water as conducted by the supplier are available upon request.
Three or four days prior to the start of the study, the hair was removed from the back and flanks of the animals using electric clippers in a way as to avoid abrasions. The clipping was repeated if considered necessary. - 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 of the test substance, moistened with 0.5 mL water - Duration of treatment / exposure:
- 4 hour exposure
- Observation period:
- Observation at 1, 24, 48, 72 hours after exposure
- Number of animals:
- 3 female rabbits
- Details on study design:
- TEST SITE
- Area of exposure: diameter: ± 2.5 cm
- % coverage: full
- Type of wrap if used: covered with a cup.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): moistened tissue
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize et al. (1944) - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 48
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 72
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- No irritation
- Other effects:
- None
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In conclusion, in the acute dermal irritation/corrosion study accordign to OECD 404, the test item L-dilactide is considered to be non-irritating.
- Executive summary:
A sample of L-dilactide (> 99.5%) was tested in female rabbits for acute dermal irritating properties according to OECD guideline 404. The dermal exposure period was 4 hours under semi-occlusive conditions. L-dilactide did not cause any skin effects. Thus, under the conditions of this study, L-dilactide can be considered non-irritating.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1998-06-04 to 1998-07-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study
- Qualifier:
- according to
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- dosing-volume of 0.01 ml powdered onto the cornea, instead of 0.1 ml instilled in the conjunctival cul-de-sac.
- Qualifier:
- according to
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Upon arrival, the rabbits were checked for overt signs of ill health and anomalies. Test animals were females, young adult and were quarantined 54 days upon arrival. At the start of the study, body weight was 2917-3085 g. Animals were housed individually in stainless steel cages with perforated floor under a 12h light / 12h dark cycle at 20 ± 3 °C and 50-76% humidity (upper limit higher than 70%, because of wet cleaning of the animal room and/or meteorological circumstances; the 76% peak occurred for one hour at most); ventilation was ca 10 air changes/hour. Animals were fed standard laboratory rabbit diet ad libitum. Each batch of this diet is analyzed by the supplier (SDS Special Diets services, Whitham, England) for the nutrients and contaminants and the results are available upon request). Tap water (N.V. Waterleidingbedrijf Midden-Nederland) was available ad libitum. Results of routine physical, chemical and microbiological examination of drinking water as conducted by the supplier are available upon request.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.01 mL of the test substance (i.e. 0.008 g, density to be: 0.8 kg/L)
- Duration of treatment / exposure:
- The rabbit selected was treated as follows: An amount of ca 0.01 ml of the test substance (i.e. ca 0.008 g; density to be ca 0.8 kg/L) was powdered onto the cornea of the right eye. After administration, the upper and lower eye lid were carefully closed and subsequently held together for at least one second before releasing, to prevent loss of material. The left eye remaining untreated, served as a control.
- Observation period (in vivo):
- The reactions of the test eyes were judged at circa 1, 24, 48, and 72 hours, and at 7 days after treatment
- Number of animals or in vitro replicates:
- 3
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.43
- Max. score:
- 1.3
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.1
- Max. score:
- 0.3
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.13
- Max. score:
- 1.7
- Reversibility:
- fully reversible within: 7d
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In conclusion, in this acute eye irritation/corrosion study according to OECD 405, L-dilactide is inducing reversible irritation in the eyes of rabbits.
- Executive summary:
L-dilactide (> 99.5%) was tested for acute eye irritating properties in an experiment with three albino rabbits according to OECD guideline 405. Undiluted substance (0.01 ml) was powdered onto the cornea and caused slight to moderate corneal opacity, slight iritis, slight to severe redness (score >2) and slight to severe swelling on the conjunctivae and severe ocular discharge in the rabbits. At 7 days after treatment, all eye effects had cleared completely.
Based on the results it was concluded, that L-dilactide is irritating for the eyes of rabbits and needs be to classified as eye irritant (CLP category 2).
Reference
Table 1: Mean values for corneal opacity, iritis, redness and swelling of the conjunctivae of each rabbit scored at 24, 48, 72 hours after treatment with L-dilactide | ||||
Animal | Opacity | Iritis | Redness | Swelling |
A19 | 0.0 | 0.0 | 0.3 | 0.0 |
A21 | 1.3 | 0.3 | 2.7 | 1.7 |
A23 | 0.0 | 0.0 | 3.0 | 1.7 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
L-dilactide (>99.5 %) was tested negative for acute dermal irritating properties according to OECD 404. After a dermal exposure period of 4 hours no skin effects were observed in rabbits. In contrast, L-dilactide was irritating in the eyes of rabbits in an acute eye irritation study (OECD 405). The effects were reversible within seven days after treatment. Based on these results, L-dilactide is considered to be not irritating to skin, but irritating to the eye.
Justification for selection of skin irritation / corrosion endpoint:
GLP study according to OECD guideline 404
Justification for selection of eye irritation endpoint:
GLP study according to OECD guideline 405.
Effects on eye irritation: irritating
Justification for classification or non-classification
L-dilactide did not cause any skin effects in an acute dermal irritating study in accordance to OECD 404. Therefore, L-dilactide does not warrant classification for skin irritation.
L-dilactide was irritating to the eyes of rabbits in an OECD 405 study. The irritation was reversible with mean scores (24, 48, 72h) of > 2.7 in two of three animals. Therefore, L-dilactide meets the classification criteria according to CLP. The substance is classified for reversible eye irritation (Eye Irrit. 2).
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