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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
2008-12-04 to 2008-12/18
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
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:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Reference substance name:
4-hydroxy-3,5-dimethoxybenzonitrile
Cas Number:
72684-95-8
IUPAC Name:
4-hydroxy-3,5-dimethoxybenzonitrile
Test material form:
solid
Specific details on test material used for the study:
- Composition of test material, percentage of components: syringonitrile 99.8%
- Expiration date of the lot/batch: May 2010
-Physical description: pale yellow powder
-solubility: soluble in water
-stability: test substance was expected to be stable for the duration of the testing.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Received from Ace Animals, Inc, Boyertown, PA, on Nov. 25, 2008
- Age at study initiation: young adult (8-9 weeks)
-Initial weight: male -- 220-244 grams, female -- 178-199 grams
-Number of animals -- 5 male/5 female (non-pregnant)
- Housing: singly housed in suspended stainless steel cage
- Diet (e.g. ad libitum): pelleted Purina Rodent Chow
- Water (e.g. ad libitum): filtered tap water was supplied ad libitum by an automatic water dispensing system.
- Acclimation period: 9 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22°C
- Humidity (%): 32-55%
- Photoperiod (hrs dark / hrs light):12 hr light/dark cycle

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: 2x3 inch (approximately 10% of body surface)
- Type of wrap if used: 3 inch durapore tape wrapping the gauze and the entire trunk of each animal

REMOVAL OF TEST SUBSTANCE
- The gauze removed and the site cleaned gently of residual substance.
- Time after start of exposure: 24 hrs

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg of body weight in a form of dry paste (65% w/w mixture in distilled water)
Duration of exposure:
24 hrs
Doses:
2000 mg/kg of body weight
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Frequency of observations and weighing: observed for mortality, gross toxicity, and behaviour changes during the first several hours after application and at least once daily thereafter for 14 days. Weights recorded before the application, day 7 and on day 14.
- Necropsy of survivors performed: yes
- Other examinations performed: At necropsy, tissues and organs of thoracic and abdominal cavities were examined.

Results and discussion

Preliminary study:
All animals survived exposure to Mediator SNP. There were no overt signs of systemic toxicity throughout the 14-day observation period and at necropsy. There were no adverse effects on body weights and body weight gains. No gross abnormalities were noted at necropsy.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
All animals survived exposure to the test substance.
Clinical signs:
other: No clinical observations other than the dermal irritations at 3 dose sites between days 1 and 3.
Gross pathology:
No gross abnormalities observed when necrospied at the end of the 14-day study.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study, the single dose acute dermal LD50 of test substance is greater than 2000 mg/kg of body weight in male and female rats.
Executive summary:

The objective of this study is to determine the potential for Mediator SNP (4-hydroxy-3,5-dimethoxybenzonitrile) to produce toxicity after topical application. The test material was moistened with distilled water and applied to the skin of 10 female rats at 2000 mg/kg body weight. The animals were observed for mortality, signs of systemic toxicity and behavioural changes daily for 14 consecutive days. Body weights were recorded and all animals were killed on day 14 post-dosing.

All animals survived exposure to Mediator SNP. There were no overt signs of systemic toxicity throughout the 14-day observation period and at necropsy. There were no adverse effects on body weights and body weight gains. No gross abnormalities were noted at necropsy. Under the conditions of this study, the acute dermal LD50 for Mediator SNP was greater than 2000 mg/kg body weight in female rats.