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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20 December 2017 to 12 January 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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
2001
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
2008
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Version / remarks:
2002
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Agricultural Production Bureau, Ministry of Agriculture, Forestry and Fisheries of Japan (JMAFF)
Version / remarks:
Appendix to Director General Notification, No. 12-Nousan-8147. November 2000, including the most recent revisions.
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
1-Naphthol, reaction products with formaldehyde
EC Number:
607-708-4
Cas Number:
25359-91-5
Molecular formula:
Not applicable - UVCB substance
IUPAC Name:
1-Naphthol, reaction products with formaldehyde
Test material form:
liquid
Details on test material:
- Appearance: Blue liquid
- Storage: At room temperature container flushed with nitrogen.
Specific details on test material used for the study:
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- The test material was used as received. Adjustment was made for specific gravity of the test material. A factor of 5 was used to correct for the purity/composition of the test material.

Test animals

Species:
rat
Strain:
Wistar
Remarks:
Crl: WI(Han)
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Females nulliparous and non-pregnant: Yes
- Age at study initiation: Young adult animals (approximately 9-10 weeks old).
- Weight at study initiation: 169 to 189 g
- Fasting period before study: Animals were deprived of food overnight (for a maximum of 20 hours) prior to dosing and until 3-4 hours after administration of the test material. Water was available.
- Housing: On arrival and following assignment to the study, animals were group housed (up to 3 animals of the same sex and same dosing group together) in polycarbonate cages containing sterilised sawdust as bedding material equipped with water bottles.
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: Mean temperature 21 °C
- Humidity: 41 - 50 %
- Air changes: Ten or greater air changes per hour with 100 % fresh air (no air recirculation) were maintained in the animal rooms.
- Photoperiod: A 12-hour light/12-hour dark cycle was maintained.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED:
- The dose volume for each animal was based on the body weight measurement prior to dosing.
- Dose volume (mL/kg body weight) was calculated as follows: Dose level (g/kg) / spec.gravity or density (g/mL) * purity correction factor.

DOSAGE PREPARATION:
The dosing formulations were stirred continuously during dose administration.

CLASS METHOD
- The toxicity of the test material was assessed by stepwise treatment of groups of 3 females. The absence or presence of mortality of animals dosed at one step determined the next step, based on the test procedure defined in the guidelines. The onset, duration and severity of the signs of toxicity were taken into account for determination of the time interval between the dose groups. The first group was treated at a dose level of 2000 mg active ingredient/kg. Based on
the results, one additional group was dosed at 2000 mg active ingredient/kg.
Doses:
2000 mg active ingredient/kg
No. of animals per sex per dose:
3 females per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Throughout the study, animals were observed for general health/mortality and moribundity twice daily, in the morning and at the end of the working day. Animals were not removed from cage during observation, unless necessary for identification or confirmation of possible findings. Postdose observations were performed at periodic intervals on the day of dosing (at least three times) and once daily thereafter. The observation period was 14 days. All the animals were examined for reaction to dosing. The onset, intensity and duration of these signs was recorded (if appropriate). Signs were graded for severity and the maximum grade was predefined at 3 or 4. Grades were coded as slight (grade 1), moderate (grade 2), severe (grade 3) and very severe (grade 4). For certain signs, only its presence (grade 1) or absence (grade 0) was scored. Animals were weighed individually on Day 1 (predose), 8 and 15. A fasted weight was recorded on the day of dosing.
- Necropsy of survivors performed: Yes. All moribund animals and animals surviving to the end of the observation period were sacrificed by oxygen/carbon dioxide procedure. All animals assigned to the study were subjected to necropsy and descriptions of all internal macroscopic abnormalities were recorded.
Statistics:
The oral LD50 value of the test material was ranked within the following ranges: 0-5, 5-50, 50-300 or 300-2000 mg active ingredient/kg b.w. or as exceeding 2000 mg active ingredient/kg b.w. The LD50 cut-off value was established based on OECD guideline 423. No statistical analysis was performed (The method used is not intended to allow the calculation of a precise LD50 value).

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
act. ingr.
Mortality:
No mortality occurred.
Clinical signs:
other: Hunched posture, uncoordinated movements, piloerection, ptosis and/or salivation were noted for the animals between Days 1 and 3.
Gross pathology:
No abnormalities were found at macroscopic post mortem examination of the animals.
Other findings:
According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg active ingredient/kg body weight.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified in accordance with EU Criteria
Conclusions:
Under the conditions of this study the oral LD50 value of the test material in Wistar rats was established to exceed 2000 mg active ingredient/kg body weight.
Executive summary:

The acute oral toxicity of the test material was investigated in accordance with the standardised guidelines OECD 423, EU Method B.1.tris, EPA OPPTS 870.1100 and JMAFF guidelines, under GLP conditions.

The objective of this study was to determine the potential toxicity of the test material when given by oral gavage at a single dose to rats of a single sex at one or more defined doses and to evaluate the potential reversibility of any findings.

The test material was administered by oral gavage to two consecutive groups of three female Wistar rats at 2000 mg active ingredient/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15).

No mortality occurred. Hunched posture, uncoordinated movements, piloerection, ptosis and/or salivation were noted for the animals between Days 1 and 3. The mean body weight gain shown by the animals over the study period was considered to be similar to that expected for normal untreated animals of the same age and strain. No abnormalities were found at macroscopic post mortem examination of the animals.

Under the conditions of this study the oral LD50 value of the test material in Wistar rats was established to exceed 2000 mg active ingredient/kg body weight.