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Toxicological information

Acute Toxicity: dermal

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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

Constituent 1
Chemical structure
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:
mercaptoacetic acid, monoester with propane-1,2,3-triol
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:
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
Main study: Red secretion, abnormal posture, tiptoeing, erythema, eschar
formation and oedema were observed.
Body weight:
Animal no. 3 showed a minimal weight loss of 1 g during the first week after dosing. The body weight development of the other animals was within the
expected range.
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.