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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:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-[[(4-methoxyphenyl)methylhydrazono]methyl]-1,3,3-trimethyl-3H-indolium acetate
EC Number:
261-448-2
EC Name:
2-[[(4-methoxyphenyl)methylhydrazono]methyl]-1,3,3-trimethyl-3H-indolium acetate
Cas Number:
58798-47-3
Molecular formula:
C20H24N3O.C2H3O2 C22H27N3O3
IUPAC Name:
2-[(4-methoxybenzyl)carbonohydrazonoyl]-1,3,3-trimethyl-3H-indolium acetate
Details on test material:
- Name of test material (as cited in study report): Basacryl Goldgelb X-GFL flüssig
- Substance type: preparation
- Physical state: liquid
- Analytical purity: 25 %

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: WIGA Sulzfeld
- Age at study initiation: -
- Weight at study initiation: males: 257 g; females: 196 g
- Fasting period before study: NA
- Housing: -
- Diet: Herilan MRH Kraftfutter (Eggersmann Rinteln/Weser) ad libitum
- Water: ad libitum
- Acclimation period: -


IN-LIFE DATES: From: 27. May 1981 To: 10. Jun 1981

Administration / exposure

Type of coverage:
not specified
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: 50 cm²
- Cover: inert plastic film

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with tempered water
- Time after start of exposure: 24 h


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4640, 3160, 2150, 2000, 1470, 1000, 681, 468, 400, 200, 100 mg/kg
- Concentration: 100 %, 50 %, 25 %, 5 % (unchanged, 500 mL/mL, 250 mL/mL, 50 mL/mL)
- Constant volume or concentration used: no


VEHICLE
- Concentration/Amount(s) applied (volume or weight with unit):
unchanged: 4640, 3160, 2150, 2000, 1470, 1000, 681 mg/kg
50 %: 681, 468, 400 mg/kg = 1.36, 0.94, 0.8 ml/kg
25 %: 200 mg/kg = 0.8 ml/kg
5 %: 100 mg/kg = 2 ml/kg
Duration of exposure:
24 hours
Doses:
4640, 3160, 2150, 2000, 1470, 1000, 681, 468, 400, 200, 100 mg/kg
No. of animals per sex per dose:
2150, 1470: 3
4640, 3160, 468, 400, 200, 100 mg/kg: 5
2000, 1000, 681 mg/kg: 8
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Investigations: Mortality, clinical signs, local effects
- Necropsy performed: yes
Statistics:
-

Results and discussion

Preliminary study:
-
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 400 - < 1 000 mg/kg bw
Mortality:
Dose [mg/kg] M F
100 0/5 0/5
200 0/5 0/5
400 0/5 1/5
464 0/5 3/5
681 1/8 3/8
1000 7/8 3/8
1470 0/3 2/3
2000 3/8 8/8
2150 1/3 2/3
3160 1/5 2/5
4640 4/5 5/5
Clinical signs:
other: Systemic clinical signs: dyspnea, apathia, excitation, abnormal posture, ataxia, atonia, missing pain- and corneal reflex, narcosis, clonic convulsions, trembling, spastic gait, ptosis, poor general condition Local effects: skin orange discolored, minim
Gross pathology:
Dead animals: heart: acute dilation of anterior chamber, acute congestive hyperemia; liver: broadened lobular pattern; adrenal cortex: orange discoloration; stomach: micro-ulzerations in glandular stomach

Surviving animals: no effects

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category III
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Ther dermal LD50 in male and female rats is between 400 and 1000 mg/kg bw.