Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
2001-12-13 to 2001-12-27
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2001

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
not specified
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report):Boric acid reaction product with MEA and TEA (CAS 68512-53-8)
- Molecular formula (if other than submission substance):not supplied
- Molecular weight (if other than submission substance):not supplied
- Smiles notation (if other than submission substance):not supplied
- InChl (if other than submission substance):not supplied
- Structural formula attached as image file (if other than submission substance): see Fig.not supplied
- Substance type:reaction product
- Physical state:liquid
- Analytical purity:not given
- Impurities (identity and concentrations):none given
- Composition of test material, percentage of components:19.3% boric acid, 17.7% monoethanolamine, 63% triethanolamine
- Isomers composition:
- Purity test date:2001-11-13
- Lot/batch No.:ESDB01441
- Expiration date of the lot/batch:2003-07-12
- Radiochemical purity (if radiolabelling):
- Specific activity (if radiolabelling):
- Locations of the label (if radiolabelling):
- Expiration date of radiochemical substance (if radiolabelling):
- Stability under test conditions:not supplied
- Storage condition of test material:approx 20 deg C in fume cupboard
- Other:

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: harlan Winkelmann GmbH, Gartenstrasse 27, D-33178 Borchen
- Age at study initiation:6-10 weeks
- Weight at study initiation:male mean 269g, female mean 207g
- Fasting period before study:not applicable
- Housing:transparent macrolon cages (type III) on soft wood granulate
- Diet (e.g. ad libitum):ad libitum - ssniff R/M-H (V 1534)
- Water (e.g. ad libitum):ad libitum - tap water
- Acclimation period:MINIMUN 5 DAYS

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/_3 deg C
- Humidity (%):50+/- %
- Air changes (per hr):air conditioned
- Photoperiod (hrs dark / hrs light):12/12

IN-LIFE DATES: From: To:not given

Administration / exposure

Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure:30 cm2
- % coverage:100% of exposure area
- Type of wrap if used:two-ply gauze and aluminum foil held in place by elastic plastic bandage

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

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):volume calculated on density of test substance (1.19 g/mL)
- Concentration (if solution):
- Constant volume or concentration used: yes
- For solids, paste formed: not applicable

VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
Duration of exposure:
24 hours
Doses:
single dose
No. of animals per sex per dose:
5 male 5 female
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:twice daily weekdays otherwise once
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:none

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
discriminating dose
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
none
Body weight:
Up to three days after decontamination three male and two female animals showed slight up to moderate erythema. Later on these animals showed scabbrd skin and skin surface with fine scales. 8 days after decontamination all signs of irritation had disappeared.
One female animal showed a loss in body weight in week one but it returned to normal at the end of the study. In the second week another female animal showed a slight loss in body weight. Development of body weight was not impaired in other animals.

Applicant's summary and conclusion

Interpretation of results:
other: not stated
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Based on the results obtained in this study the median lethal dose value (LD50) of CAS 68512-53-8 for male and female rats is greater than 2000 mg/kg body weight.
Executive summary:

Acute dermal toxicity testing of CAS 68512 -53 -8 in the rat yielded a median lethal dose (LD50) above 2000 mg/kg body weight in both male and female animals.

After administration of 2000 mg/kg body weight neither deaths nor symptoms of systemic toxicity occured.

Up to three days after decontamination three male and two female animals showed slight up to moderate erythema. Later on these animals showed scabbrd skin and skin surface with fine scales. 8 days after decontamination all signs of irritation had disappeared.

One female animal showed a loss in body weight in week one but it returned to normal at the end of the study. In the second week another female animal showed a slight loss in body weight. Development of body weight was not impaired in other animals.

All animals were killed at the end of the observation period. they showed no macroscopically visible changes.