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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
N/A to 1983-08-19
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study was conducted similar to OECD guideline 402 (Acute Dermal Toxicity) with limited details on test material and methods.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
limited details on test material and methods
Principles of method if other than guideline:
N/A
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Methyl 3-mercaptopropionate
EC Number:
220-912-4
EC Name:
Methyl 3-mercaptopropionate
Cas Number:
2935-90-2
Molecular formula:
C4H8O2S
IUPAC Name:
methyl 3-sulfanylpropanoate
Details on test material:
- Name of test material (as cited in study report): methyl 3-mercaptopropionate
- Molecular formula (if other than submission substance): N/A
- Molecular weight (if other than submission substance): N/A
- Smiles notation (if other than submission substance): N/A
- InChl (if other than submission substance): N/A
- Structural formula attached as image file (if other than submission substance): N/A
- Substance type: active
- Physical state: liquid
- Stability under test conditions: N/A
- Storage condition of test material: N/A
- Other: N/A

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dutchland Laboratory Animals, Inc.
- Age at study initiation: young adult
- Weight at study initiation: 2 to 3 kg
- Fasting period before study: N/A
- Housing: individual
- Diet: Purina lab Rabbit Chow, ad libitum
- Water: tap water, ad libitum
- Acclimation period: minimum of one week


ENVIRONMENTAL CONDITIONS
- Temperature (deg. C): 70 +/- 4 degrees F
- Humidity (%): 40-60%
- Air changes (per hr): N/A
- Photoperiod (hrs dark / hrs light): 12 hour light-dark cycle


IN-LIFE DATES: From: N/A To: N/A

Administration / exposure

Type of coverage:
other: do not have enough information but know it is not open.
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Area was shaved off 24 hours prior to initiation of the study and liquid test material was applied to the back
- % coverage: approximately 10% of the total body surface
- Type of wrap if used: non-absorbent binder


REMOVAL OF TEST SUBSTANCE
- Washing (if done): The exposed area of the animals was wiped (but not waashed) to remove any test material remaining.
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): N/A
- Concentration (if solution): N/A
- Constant volume or concentration used: N/A
- For solids, paste formed: N/A


VEHICLE
- Amount(s) applied (volume or weight with unit): N/A
- Concentration (if solution): N/A
- Lot/batch no. (if required): N/A
- Purity: N/A
Duration of exposure:
24 hours
Doses:
1000, 1500, 2000, and 2500 mg/kg bw
No. of animals per sex per dose:
3/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: Body weights were recorded at study initiation, at Day 7 and Day 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,dermal irritation, gross pathology. Skin was evaluated on Days 1, 3, 7, 10, and 14.
Statistics:
N/A

Results and discussion

Preliminary study:
N/A
Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
1 930.4 mg/kg bw
95% CL:
1 222.5 - 3 048.5
Sex:
female
Dose descriptor:
LD50
Effect level:
1 890.8 mg/kg bw
95% CL:
1 383.6 - 2 583.8
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 903.7 mg/kg bw
95% CL:
1 462.1 - 2 478.7
Mortality:
All animals in the 1000 mg/kg dose group survived. In the 1500 mg/kg dose group, one male died after one hour, one male and one female died after 4 hours. In the 2000 mg/kg dose group, one male and one female died after 1 hour, one female died after 4 hours. Two males in the 2500 mg/kg dose group died after 4 hour, two females in the 2500 dose group died after 1 hour.
Clinical signs:
other: All animals dosed at 1000 mg/kg bw appeared normal during the study with exception of slight depression in one male at 1 hour and one female at 4 hours. Effects of toxicity in the remaining animals were noted by 1 hour post dosing and included one or mor
Gross pathology:
Gross pathological findings among rabbits found dead were limited to dark red lungs in one female dosed at 2000 mg/kg bw. There were no observable gross pathological findings related to test material administration in any of the rabbits surviving to termination.
Other findings:
- Other observations: Irritation: With one exception, dermal irritation scores could not be made in the animals that died during the study because they were found dead prior to Day 1 observation. No dermal irritation was noted on Day 1 in the one female dosed at 2000 mg/kg bw that was found dead on Day 2. Erythema among survivors ranged from very slight to well-defined. Very slight erythema was noted in one female dosed at 1000 mg/kg on Day 3 and in one male and two females dosed at 1500 mg/kg on Day 1 only. Well-defined erythema was noted in one male and one female dosed at 2500 mg/kg bw on Day 1 and decreased in the male to very slight on Day 3, clearing in the female by Day 3 and in the male by Day 7. No edema was noted in any of the animals. Other dermal effects were noted in anlmals dosed at 2000 mg/kg. Epidermal scaling was noted in one male on Days 7 and 14 and one female on Day 14. Necrosis was noted in one male and female on Day 10 only.

Any other information on results incl. tables

Individual Dermal Irritation Scores Using Draize Scale for Scoring Dermal Irritation

Animal No.

Erythema Score

Edema Score

 

Day

Day

 

1

3

7

10

14

1

3

7

10

14

1000 mg/kg bw

 

 

Male 1

0

0

0

0

0

0

0

0

0

0

Male 2

0

0

0

0

0

0

0

0

0

0

Male 3

0

0

0

0

0

0

0

0

0

0

Female 1

0

0

0

0

0

0

0

0

0

0

Female 2

0

0

0

0

0

0

0

0

0

0

Female 3

0

0

0

0

0

0

0

0

0

0

1500 mg/kg bw

 

 

Male 1

Found dead

Found dead

Male 2

Found dead

Found dead

Male 3

1

0

0

0

0

0

0

0

0

0

Female 1

1

0

0

0

 

0

0

0

0

0

Female 2

1

0

0

0

0

0

0

0

0

0

Female 3

Found dead

Found dead

2000 mg/kg bw

 

 

Male 1

0

0

0

0

0

0

0

0

0

0

Male 2

Found dead

Found dead

Male 3

0

0

0

0

0

0

0

0*

0**

0*

Female 1

Found dead

Found dead

Female 2

0

Found dead

0

Found dead

Female 3

0

0

0

0

0

0

0

0

0**

0*

2500 mg/kg bw

 

 

Male 1

Found dead

Found dead

Male 2

Found dead

Found dead

Male 3

2

1

0

0

0

0

0

0

0

0

Female 1

2

0

0

0

 

0

0

0

0

0

Female 2

Found dead

Found dead

Female 3

Found dead

Found dead

Where

* = epidermal scaling

** = necrosis

Additional calculated LD values and 95% confidence limits:

The LD16 for males was 1095.3 mg/kg with a 95% confidence limit of 507.6 to 2363.5 mg/kg. The LD16 for females was 1298.4 mg/kg with a 95% confidence limit of 806.9 to 2089.1 mg/kg. The LD16 combined was 1201.9 mg/kg with a 95% confidence limit of 792.4 to 1822.8 mg/kg.

The LD 84 for males was 3402.3 mg/kg with a 95% confidence limit of 1231.7 to 9398.3 mg/kg. The LD84 for females was 2753.5 mg/kg with a 95% confidence limit of 1588.3 to 4773.4 mg/kg. The LD84 combined was 3015.4 mg/kg with a 95% confidence limit of 1796.1 to 5062.5 mg/kg.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Remarks:
Migrated information
Conclusions:
This study evaluated the dermal toxicity of the test substance following a single dermal application to rabbits. The acute dermal LD50 was calculated to be 1903.7 with a 95% confidence limit of 1462.1 to 2478.7 mg/kg in male and female rabbits.
Executive summary:

N/A