Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 604-012-2 | CAS number: 137296-15-2
- 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
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- 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
The target substance did not cause any skin and/or eye effects in an acute dermal and an acute eye irritation study, which were conducted in accordance with OECD test guideline 404 and 405, respectively.
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:
- 2003-07-25 to 2003-10-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Ammonium-S-Lactate
- Physical state: clear colourless liquid
- Analytical purity: ca. 70 %
- Composition of test material, percentage of components: ca. 70 % ammonium lactate, ca. 30 % water
- Lot/batch No.: 2991200039
- Expiration date of the lot/batch: 2005-02-10
- Stability under test conditions: stable
- Storage condition of test material: at room temperature in the dark - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: at least 6 weeks
- Weight at study initiation: at least 1.0 kg
- Housing: individually in labelled cages with perforated floors
- Diet: standard laboratory rabbit diet approx. 100 g per day; in addition, pressed hay was provided twice a week, ad libitum
- Water: tap-water (quarterly analysis of quality available at test site), ad libitum
- Acclimation period: at least 5 days before start of treatment under laboratory conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.1-23.9 °C
- Humidity (%): 44-81 %; according to the test laboratory cleaning procedures in the room might have caused the temporary fluctuations above the optimal level of 70 % for relative humidity. Based on laboratory historical data these conditions were considered not to have affected the study integrity.
- Air changes (per hr): 15 per hour
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 70 % - Duration of treatment / exposure:
- 4 h
- Observation period:
- 1, 24, 48 and 72 h
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: 2 × 3 cm (6 cm²)
- Type of wrap if used: the test substance was applied to the skin of one flank, using a metalline patch (2 x 3 cm); the patch was mounted on Micropore tape, which was wrapped around the abdomen and secured with Coban elastic bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the dressing was removed and the skin was cleaned of residual test substance using water
- Time after start of exposure: 4 hours
SCORING SYSTEM:
The irritation was assessed according to the following numerical scoring system. At each observation, the highest scores given were recorded:
Erythema and eschar formation:
No erythema .......................................................................................................................... 0
Very slight erythema (barely perceptible) .............................................................................1
Well-defined erythema ......................................................................................................... 2
Moderate to severe erythema ............................................................................................. 3
Severe erythema (beet redness)* ....................................................................................... 4
* Where signs of necrosis or corrosion (injuries in depth) prevent erythema scoring, the maximum grade for erythema(= 4) is given.
Oedema formation:
No oedema ............................................................................................................................................. 0
Very slight oedema (barely perceptible) ........................................................................................... 1
Slight oedema (edges of area well-defined by definite raising) .................................................... 2
Moderate oedema (raised approximately 1 millimeter) .................................................................. 3
Severe oedema (raised more than 1 millimeter and extending beyond the area of exposure) 4 - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within:
- Remarks:
- 24 h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Irritation (please refer to Table 1 in box " Any other information on results incl. tables"):
Four hours exposure to 0.5 mL of the test item resulted in very slight erythema in the treated skin-area of one rabbit, which had resolved within 24 hours.
Corrosion:
There was no evidence of a corrosive effect on the skin. - Other effects:
- Colouration:
No staining of the treated skin by the test substance was observed.
Toxicity/mortality:
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an acute dermal irritation/corrosion study conducted according to OECD 404, the test item was found to be non-irritating.
- Executive summary:
In a primary dermal irritation study (OECD guideline 404), three male New Zealand white rabbits were dermally exposed to 0.5 mL of the test item (70% solution) for 4 hours to a body surface area of 6 cm² under semi-occlusive conditions. Animals then were observed for 1, 24, 48 and 72 hours after removal of the dressings and test substance. The test item did not cause any skin effects, except a very slight erythema in the treated skin-area of one rabbit, which had resolved within 24 hours. Based on the results, the test item is considered to be non-irritating.
Reference
Table 1: Individual skin irritation scores
Animal # |
513 (sentinel) |
537 |
538 |
||||||
Time after exposure |
Erythema |
Oedema |
comments |
Erythema |
Oedema |
comments |
Erythema |
Oedema |
comments |
1 hour |
1 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
24 hours |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
48 hours |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
72 hours |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
Table 2: Mean value irritation scores
Animal # |
Mean 24 - 72 hrs |
|
Erythema |
Oedema |
|
513 |
0 |
0 |
537 |
0 |
0 |
538 |
0 |
0 |
Table 3: Animal specifications
Animal # |
Sex |
Age at start (weeks) |
Body weights (g) |
|
prior to application |
at termination |
|||
513 |
M |
8-10 |
1883 |
1998 |
537 |
M |
7-9 |
1407 |
1509 |
538 |
M |
7-9 |
1481 |
1601 |
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:
- 2005-04-06 to 2005-06-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted 24th April 2002
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Ammonium Lactate, PURASAL® NH
- Physical state: yellowish-white liquid
- pH: 5
- Analytical purity: not reported
- Impurities (identity and concentrations): not reported
- Composition of test material, percentage of components: not reported
- Isomers composition: not reported
- Lot/batch No.: 0503002615
- Expiration date of the lot/batch: 2007-09-28
- Stability under test conditions: not reported
- Storage condition of test material: room temperature (20 ± 5 °C) in the dark - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Granja Cunicola San Bernardo, S.L., Tulebras, Navarra, Spain
- Age at study initiation: 14-15 weeks
- Weight at study initiation: 3.1-3.5 kg
- Housing: individually in stainless steel cages (52 × 58 × 43 cm) with a grille floor and placed on a rack
- Diet: free access to a standard diet
- Water: ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 40-70
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated left eye was used as a control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): undiluted, 100% - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- ADMINISTRATION OF THE TEST ITEM
Both eyes of the animals were examined before treatment in order to reject them if they showed any signs of eye alterations. One single application of the test item was done.The administration was carried out with the animal immobilised and the test item was dropped into the right conjunctival sac, made perfectly accessible by carefully pulling the lower lid outwards. Once the test item had been administered, the lids of the treated eye were held
together for one second. Immediately after administration, the rabbits were fitted with a plastic collar for 1 hour to prevent them from rubbing their eyes.
OBSERVATIONS
The behaviour of the animals was observed immediately following instillation of the product and they were then returned to their cages and observed at regular intervals so as not to miss any serious effect of the test item. The degree of ocular irritation was assessed after approximately 1 hour, and approximately 24, 48, 72 hours, 7 and 14 days after the treatment, following the criteria described below. For the direct examination, the assessments were carried out in the following order: conjunctivae (edema, redness, lacrimation), iris and cornea (degree and extent of opacity). Subsequently, and at all the observations except the one at one hour after administration, the observation of the cornea was completed with the instillation of an aqueous solution of 2 % sodium fluorescein (Colircusi Fluoresceina®, Laboratorios Cusi, S.A., Batch 4CRK1A). This procedure involved the instillation of the aqueous solution of fluorescein in the test area, followed by washing the area with a 0.9 % physiological saline solution. Once the excess fluorescein had been removed, the corneal alterations were observed with the aid of a transilluminator with a cobalt blue filter
SCORING SYSTEM: According to OECD guideline 405 - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 27 h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of weak irritation
- Irritant / corrosive response data:
- The test item was administered initially to one animal (no. 1997). One and 24 hours after the application, some blood vessels hyperaemic (injected) (grade 1) and some swelling above normal (grade 1) was recorded, accompanied by slight lacrimation in the case of the observation carried out 24 hours after the administration. Forty-eight hours after the administration, some hyperaemic blood vessels (injected) (grade 1) were still observed in this animal, but the edema had remitted completely. No ocular lesions were recorded in this animal 72 hours, 7 or 14 days after the administration.
The test item was afterwards applied to two more animals (nos. 2011 and 2012). One hour after the administration, one of these animals (no. 2011) was seen to have redness diffuse, crimson colour, individual vessels not easily discernible (grade 2) accompanied by obvious swelling, with partial eversion of the lids (grade 2). Twentyfour hours afterwards, diffuse redness, crimson colour, and individual vessels not easily discernible (grade 2), were still observed, but the edema had diminished to some swelling above normal (grade 1 ). One hour and 24 hours after the application, slight lacrimation was also observed in this animal. Forty-eight hours after the administration, some hyperaemic blood vessels (injected) (grade 1) were observed. No ocular lesions were recorded 72 hours, 7 or 14 days after the administration.
One, 24 and 48 hours after the administration, diffuse redness, crimson colour, and individual vessels not easily discernible (grade 2) were observed in the remaining animal (no. 2012). One hour after the administration, swelling, with the lids about half closed (grade 3), was also recorded in this animal. This lesion diminished progressively to obvious swelling, with partial eversion of lids (grade 2) during the observation carried out 24 hours after the application, and to some swelling above normal (grade 1) during the observation carried out 48 hours after the application. Slight lacrimation (grade 1) was also recorded in this animal one hour and 24 hours after the treatment. Seventy-two hours and 7 days after the application, some hyperaemic blood vessels (injected) (grade 1) were observed, which had remitted completely 14 days after the administration. - Other effects:
- CLINICAL SIGNS AND BODY WEIGHT
The behaviour and physical state of the rabbits, and the body weight evolution were normal throughout the study. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an acute eye irritation/corrosion study conducted according to OECD 405, the test item is considered to be non-irritant.
- Executive summary:
In a primary eye irritation study (OECD 405) 0.1 mL of the test item was instilled into the conjunctival sac of one eye of each of three young adult New Zealand White rabbits. Animals were observed for 14 days. Irritation was scored by the method of Draize. The behaviour and physical state of the rabbits, and the body-weight evolution were normal throughout the study. Only very mild conjunctival reactions were observed, which were fully reversible within 72 hours (two animals), and for the third animal within 14 days. Based on the results, the test item can be considered as not irritating.
Reference
Table 1: Body weight (kg)
|
|
Observation period |
||||
Animal # |
Day of treatment |
24h |
48h |
72h |
7d |
14d |
1997 |
3.49 |
3.52 |
3.54 |
3.52 |
3.65 |
3.76 |
2011 |
3.21 |
3.23 |
3.29 |
3.27 |
3.39 |
3.51 |
2012 |
3.06 |
3.04 |
3.09 |
3.08 |
3.18 |
3.29 |
Table 2: Primary Eye Irritation Test
Animal # |
Region of eye |
Observation period |
||||||
1h |
24h |
48h |
72h |
7d |
14d |
|||
1997 |
Cornea |
Density |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
|
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae |
Hyperaemia |
1 |
1 |
1 |
0 |
0 |
0 |
|
Edema |
1 |
1 |
0 |
0 |
0 |
0 |
||
2011 |
Cornea |
Density |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
|
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae |
Hyperaemia |
2 |
2 |
1 |
0 |
0 |
0 |
|
Edema |
2 |
1 |
0 |
0 |
0 |
0 |
||
2012 |
Cornea |
Density |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
|
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae |
Hyperaemia |
2 |
2 |
2 |
1 |
1 |
0 |
|
Edema |
3 |
2 |
1 |
0 |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Ammonium-S-lactate was tested negative for skin and eye irritating properties in studies conducted according to OECD test guidelines 404 and 405. Thus, in accordance with CLP Regulation 1272/2008 no classification for eye or skin irritation is warranted.
Justification for classification or non-classification
Ammonium-S-lactate did not cause any skin and/or eye effects in an acute dermal and in an acute eye irritating study in accordance with OECD test guideline 404 and 405. Based on these results, classification of ammonium-S-lactate is not warranted.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.