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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

A in-vitro study on skin irritation/corrosion according to OECD guideline 439 (EPISKIN) revealed no irritation following a 15 minutes exposure period. An in-vitro study on eye irritation according to OECD guideline 437 (BCOP) revealed

no severe eye irritating or corrosive properties.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
18 May 2011 - 15 November 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
other: OECD 439
Deviations:
no
Principles of method if other than guideline:
The objective of this study was to assess the skin irritation potential, in vitro, of the test substance. The test was conducted in accordance with the Standard Operating Procedure, In Vitro Skin Irritation Test: Human Epidermis Model (L’Oreal 2009), supplied by L’Oreal (leading laboratory in the validation of the test for ECVAM) and the OECD 439 Guideline For The Testing of Chemicals: In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method (OECD439).
GLP compliance:
yes (incl. QA statement)
Species:
other:
Strain:
other:
Controls:
not required
Amount / concentration applied:
The positive and negative controls were in liquid form and were applied by dispensing a volume of 10 μl over each tissue using a positive displacement pipette. A weight of 10 ±2 mg of the test substance, LZ1554, a highly viscous brownish liquid, was applied to the tissue using the curved edge of a spatula. In order to spread 10 ±2 mg, a higher amount of 12 ±2 mg was weighed to compensate for some of the substance sticking to the spatula.
Duration of treatment / exposure:
After incubation of at least 24 hours in maintenance medium, triplicate tissues were dosed for 15 minutes with the test substance, negative or positive control at room temperature. A maximum of four samples were applied in a block with a minimum of 1 minute intervals between each application of substance. On application of 10 μl, the positive control was spread over the tissue for approximately 30 seconds and then respread with a curved flat spatula after approximately 7 minutes application time.
After 15 minutes, each tissue was rinsed with 25 ml sterile Dulbeccos Phosphate Buffered Saline (DPBS) to remove residual test substance. The surface of the tissues treated with the test substance, LZ1554, were also gently swabbed to remove residual test material. Inserts were then blotted on absorbent paper to remove remaining DPBS. Each insert was then transferred to a well containing 2 ml maintenance medium and incubated for 42 ± 1 hour at 37 ± 2°C in a humidified atmosphere of 5% CO2 in air.
After 42 ± 1 hour, each insert was transferred to a well containing 2 ml of 0.3 mg/ml MTT and incubated for 3 hours ± 5 minutes at 37 ± 2°C in a humidified atmosphere of 5% CO2 in air.
Observation period:
At the end of 3 hours ± 5 minutes, the triplicate inserts were blotted on absorbent paper. The epidermis was removed from the insert using a biopsy punch, the epidermis separated from the collagen matrix using forceps and both parts placed in a micro tube. When all tissues had been punched, the tissues were vortexed with 500 El of acidic isopropanol (0.04 N HCl final concentration).
The tissues were extracted by storing at 2-8 ºC, protected from light, for 70 hours.
Number of animals:
No animals were used as the method carried out was an in-vitro method.
Irritation / corrosion parameter:
other: other: tissue viabiity
Value:
107.8
Remarks on result:
other:
Remarks:
Basis: mean. Time point: 42 hours. Max. score: 111.9. (migrated information)
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
It was concluded that the test substance, LZ1554, with a mean tissue viability of 107.8 ± 5.4%, was predicted as non-irritant to the skin.
Executive summary:

The skin irritation/corrosion potential was determined in a GLP-compliant study in accordance with OECD guideline no. 439 (EPISKIN method). It was concluded that the test substance, LZ1554, with a mean tissue viability of 107.8 ± 5.4%, was predicted as non-irritant to the skin.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
08 February 2011 - 29 July 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
other: OECD 437
Deviations:
no
Principles of method if other than guideline:
The Bovine Corneal Opacity & Permeability Assay (BCOP) which was developed by Pierre Gautheron 1992 as an in vitro alternative to the in vivo Draize Eye Irritation test. The assay uses isolated bovine corneas as a means of assessing the ocular irritancy potential of test substances in vitro.
GLP compliance:
yes (incl. QA statement)
Details on test animals or tissues and environmental conditions:
Test animals are not used in this In-Vitro study.
Amount / concentration applied:
Corneas were treated in triplicate with either the test substance, positive control (10% w/v sodium hydroxide) or negative control (0.9% sodium chloride solution).
Duration of treatment / exposure:
The test material or controls were in contact with the cornea for a total of 10 minutes (± 30 seconds). Each holder was incubated in a horizontal position at 32°C ± 1°C in a waterbath.
Observation period (in vivo):
Following completion of the two hour incubation period, the medium was removed from both compartments and replaced with fresh cMEM. The posterior compartment was re-plugged and the opacity of each cornea measured and recorded. The opacity values obtained at this stage were used in calculating the final In Vitro Irritancy Score.
Number of animals or in vitro replicates:
No animals used as method carried out was an in-vitro method.
Irritation parameter:
in vitro irritation score
Value:
0.5
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
The test substance, LZ1554, elicited an In Vitro Irritancy Score of 0.5 ± 1.9 and was predicted to be a non corrosive/ non severe eye irritant.
Executive summary:

The eye irritation potential was determined in a GLP-compliant study in accordance with OECD no. 437 (BCOP method). The test substance, LZ1554, elicited an In Vitro Irritancy Score of 0.5 ± 1.9 and was predicted to be a non corrosive/ non severe eye irritant.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Based on the data available the substance is not classified or labeled according to Directive 67/548/EEC (DSD) or Regulation 1272/2008/EC (CLP).