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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
04 March, 1980 - 18 March,1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Remarks:
Study is not conducted according to GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
1981
Deviations:
yes
Remarks:
No details on test material, no purity, no details on environmental conditions, test site not covered.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

1
Chemical structure
Reference substance name:
Methyl 2,4-dihydroxy-3,6-dimethylbenzoate
EC Number:
225-193-0
EC Name:
Methyl 2,4-dihydroxy-3,6-dimethylbenzoate
Cas Number:
4707-47-5
Molecular formula:
C10H12O4
IUPAC Name:
methyl 2,4-dihydroxy-3,6-dimethylbenzoate
Test material form:
other: solid

Test animals

Species:
rat
Strain:
other: Albino (Sprague-Dawley CD strain)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Labs (Wilmington, Mass.)
- Age at study initiation: Young adults
- Weight at study initiation: Males: 205 - 252 g; Females: 188 - 212 g
- Housing: Singly housed in wire cages
- Diet: Free access to Purina Rodent Laboratory Chow 5001
- Water: Free access to water
- Acclimation period: Seven days

ENVIRONMENTAL CONDITIONS
No data.

Administration / exposure

Type of coverage:
open
Vehicle:
ethanol
Details on dermal exposure:
TEST SITE
- Area of exposure: The site of application was approximately that area bounded by the nape of the neck, the mid dorsum between pectoral and pelvic girdles and the lateral aspects of the scapulae.
- % coverage: Judged to comprise less than 30%
- Type of wrap if used: None, open.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): None, any excess material was removed by wiping with a clean cloth.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.0 mL/100 g body weight
Duration of exposure:
24 hours
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
8
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for mortality and pharmacotoxic signs at 1, 3, 5 and 24 hours following dosing and twice daily (once daily on weekends) for the remainder of the 14 day observation period. Surviving animals were weighed at the end of the observation period.
- Necropsy of survivors performed: yes, the animals were killed using ether inhalation.
Statistics:
Not performed.

Results and discussion

Preliminary study:
Two rats (one of each sex) received a dose of 5000 mg/kg bw. There were no deaths over the 72 hour observation period.
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred.
Clinical signs:
other: There were no clinical signs of toxicity in any animal dosed. All the animals appeared normal in health and behaviour throughout the fourteen day observation period.
Gross pathology:
There were no signs indicative of toxicity in any of the animals necropsied at termination.

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Remarks:
According to Regulation (EC) No. 1272/2008.
Conclusions:
The acute dermal toxicity test showed an LD50 of >5000 mg/kg bw.
Executive summary:

In this study performed equivalent to OECD TG 402 guideline without GLP, 16 rats (8 males and 8 females) were administered to the substance at a dose level of 5000 mg/kg bw. No deaths occurred.

There were no clinical signs of toxicity in any animal dosed. All the animals appeared normal in health and behaviour throughout the fourteen day observation period.

The animals all gained weight in a normal pattern. There were no signs indicative of toxicity in any of the animals necropsied at termination.

The acute dermal LD50 for the substance in male and female rats was determined to be >5000 mg/kg bw and the substance does not have to be classified for acute toxicity by the oral route according to Regulation (EC) No. 1272/2000 and GHS.