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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:
2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
impurity
Test material form:
solid: particulate/powder
Details on test material:
Batch : 20180328 (28 March 2018)
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Batch n°20180328
- Expiration date of the lot/batch:28 March 2019

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability under test conditions: Yes

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: JANVIER LABS (53940 Le Genest St Isle – France)
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: 8 - 9 weeks old
- Weight at study initiation: 219.3 g +/- 8 g (mean)
- Housing: individual cage
- Diet :ad libitum (ENVIGO 2016)
- Water : ad libitum (tap-water from public distribution system - Microbiological and chemical analyses of the water were carried out once every 6 months)
- Acclimation period: Yes - Five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C to 25°C
- Humidity (%): 30% to 70%
- Air changes (per hr): ten changes cycles per hour
- Photoperiod (hrs dark / hrs light): 12h dark / 12h light

Administration / exposure

Type of coverage:
open
Vehicle:
DMSO
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: 10%
- Type of wrap if used: wides hypoallergenic microporeTM adhesive tape from 3M

REMOVAL OF TEST SUBSTANCE
- Washing : Yes (distiled water)

TEST MATERIAL
- Amount(s) applied: 1.006 g with 5 ml of DMSO or 2.006 g with 10 mL of DMSO

VEHICLE
- Amount(s) applied: 10 mL/kgbw
Duration of exposure:
24 hours
Doses:
2 000 mg/kgbw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 0, 2, 7 and day 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs (spontaneous activity, preer's reflex, respiratory rate, convlusions, tremors, body temperature, muscle tone, palpebral opening, pupil appearance, salivation, lachrymation, righting reflex), body weight, Auopsy (oesophagus, stomach, duodenum, jejunum, ileon, caecum, colon, rectum, spleen, liver, thymus, trachea, lungs, heart, kidneys, urinary bladder, ovarie, uterus, skin, adrenals, pancrease), only organs presenting macroscopic anomalies can be removed and preserved in view to microscopic examination.
- These observations were compared to historical control data
Statistics:
Mean and standard deviation

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality
Clinical signs:
No systemic clinical sign
Body weight:
The body weight evolution of the animals remained normal throughout the study.
Gross pathology:
No gross pathology

Any other information on results incl. tables

Body weight and weight gain in grams

 Females D0  D2  D2 -D0  D7  D7 -D0  D14  D14 -D0 
Female n°1  211  233  22  253  42  282  71 
 Female n°2 220 229  254  34  271  51 
 Female n°3 227  241  14  263  36  271  44 
 MEAN 219.3  234.3  15.0  256.7  37.3  274.7  55.3 
 Standard deviation 8.0  6.1  6.6  5.5  4.2  6.4  14.0 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 of the test item Paraphenoxyphenol is higher than 2000 mg/ kg body weight by dermal route in the rat.
Executive summary:

In accordance with the OECD guideline n° 402, the 4 -Paraphenoxyphenol was applied, as supplied, onto the intact skin of 3 female Sprague Dawley rats at the dose of 2000 mg/kg body weight.

No mortality occurred during the study. No systemic clinical sign related to the administration of the test item was observed. The body weight evolution of the animals remained normal throughout the study. The macroscopic examination of the animals at the end of the study did not reveal treatment-related changes.

In conclusion, the LD50 of the test item Paraphenoxyphenol is higher than 2000 mg/ kg body weight by dermal route in the rat. The test item Paraphenoxyphenol does not have to be classified in accordance with the Regulation 1272/2008 on classification, labelling and packaging of substances and mixtures.