Mercaptoacetic acid, monoester with propane-1,2,3-triol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

01-Dec-2008 - 16-Feb-2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 434 (Acute Dermal Toxicity - Fixed Dose Procedure)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, Landesinstitut für Arbeitsschutz und Produktsicherheit

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Mercaptoacetic acid, monoester with propane-1,2,3-triol

EC Number:

250-264-8

EC Name:

Mercaptoacetic acid, monoester with propane-1,2,3-triol

Cas Number:

30618-84-9

Molecular formula:

C5H10O4S

IUPAC Name:

2,3-dihydroxypropyl 2-sulfanylacetate

Test material form:

solid - liquid: suspension

Details on test material:

- Name of test material (as cited in study report): Glyceryl Thioglycolate 80 %
- Analytical purity: 80.5 % (iodometric, based on mercapto group, calculated for Glycerylmonothioglycolate)

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France 53940
- Age at study initiation: Within 8 - 12 weeks
- Weight at study initiation: 192 - 209 g
- Fasting period before study: no data
- Housing: The animals were kept individually in IVC cages, type III H, polysulphone cages on Altromin saw fiber bedding
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: At least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- % coverage: No less than 10% of the body surface was cleared for the application

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Isotonic saline
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

4

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were weighed on day 0 (prior to the application) and on days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: A careful clinical examination was made several times on the day of dosing (at least once during the first 30 minutes and with special attention given during the first 4 hours post-dose). As soon as the symptoms noticed they were recorded. Thereafter, the animals were observed for clinical signs once daily until the end of the observation period.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

none

Clinical signs:

other: Signs of toxicity related to dose level used: Sighting study: Apathy, ataxia, extended hind legs, extended hind legs, tiptoeing, circular movements, abnormal posture, complete eye-closure, red tears from the eyes to the nose, and grooming were observed Ma

Gross pathology:

Effect on organs (related to dose level):
Sighting study: No treatment related effects were observed in any of the animals.
Main study: No treatment related effects were observed in any of the animals.

Any other information on results incl. tables

Table 1: Clinical observations

Animal no./ sex	Time of observation (post dose)	Observations
1 / female (sighting study)	30 minutes	Ataxia, extended hind legs
	1 hour	Apathy, ataxia, circular movements, extended hind legs, tiptoeing
	4 h 15 min	Apathy, ataxia, circular movements, extended hind legs, tiptoeing , red tears from the eyes to the nose
	23 hours	Apathy, complete eye closure, abnormal posture (Head and breast recumbent while hind legs standing)
	24 hours	Starting with grooming; (after patch removal)
	25 hours	Reddish swollen eyelids
	day 2	No findings
2 / female (main study)	2 hours	Red secretion at the nose
	4 hours	Red secretion at the nose, abnormal posture (head and breast recumbent while hind legs standing)
	days 1 - 7	skin irritation
	day 8	Red secretion at the nose
	day 9	No findings
3 / female (main study)	2 and 4 hours	Red secretion at the nose
	3 - 5 days	Skin irritation
	day 6	No findings
4 / female (main study)	30 min	Tiptoeing, vocalisation (slightly)
	2 and 4 hours	Red secretion at the nose, tiptoeing
	day l	Abnormal posture (head and breast recumbent while hind legs standing)
	days 2 - 13	Skin irritation
	day 14	No findings
5 / female (main study)	30 min, 2 hours	Secretion at the nose
	4 hours	Red secretion at the nose
	day 1	Abnormal posture (head and breast recumbent while hind legs standing)
	days 2 - 13	Skin irritation
	day 14	No findings

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

The dermal LD50 was determined to be greater than 2000 mg/kg body weight. Therefore the substance is unclassified according to GHS.