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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Justification for type of information:
No data are available for the target substance. Acute oral LD50 values of 121mg/kg bw, 242 mg/kg bw and 207 mg/kg bw are reported for o-, m- and p-cresols, respectively. Acute oral LD50 values of ~980 mg/kg bw are reported for xylenol and ethylphenol. Data therefore demonstrate greater toxicity for the cresols compared to mixed xylenol isomers and mixed ethylphenol isomers, with some evidence that o-cresol is the more toxic of the cresol isomers. Based on the closest structural similarity, read-across using the xylenol study is required for this endpoint. No dermal toxicity data are available for any Category substance; a waiver is appropriate for the target substance for this endpoint based on the proposed classification of the target substance as corrosive. Robust inhalation toxicity data are available for any Category substance; a waiver is appropriate for the target substance for this endpoint based on the proposed classification of the target substance as corrosive. Experimental data for o-, m- and pcresols, 2,4-xylenol and 2,6-xylenol show that classification for skin corrosivity is appropriate. Data for 3,5-xylenol do not indicate that classification for skin irritation or corrosivity are required. Classification for skin corrosivity is therefore proposed for the target substance based on the weight of evidence and following a worst case approach. Experimental data for o-, m- and p-cresols and 3,5-xylenol show severe eye irritation. Classification for severe eye damage is therefore proposed for the target substance based on the weight of evidence. Skin sensitisation studies report negative results for p-cresol and 3,5-xylenol and a positive result for 2,4-xylenol. Classification for skin sensitisation is therefore proposed for the target substance based on the weight of evidence and following a worst-case approach.

Data source

Materials and methods

Principles of method if other than guideline:
Method: other: 5 rabbits/dose, exposure period not given, observation up to 14 days, gross autopsy
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of 2,4-xylenol and 2,5-xylenol
EC Number:
905-287-4
Cas Number:
1638758-52-7
Molecular formula:
(CH3)2C6H3OH
IUPAC Name:
Reaction mass of 2,4-xylenol and 2,5-xylenol
Test material form:
solid: bulk

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
no further data

Administration / exposure

Type of coverage:
not specified
Vehicle:
other: undiluted
Details on dermal exposure:
no further data
Duration of exposure:
no data
Doses:
681, 1000, 1470, 2150 mg/kg bw
No. of animals per sex per dose:
5 rabbits/dose
Control animals:
not specified
Details on study design:
no further data
Statistics:
yes, but method not mentioned

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
1 380 mg/kg bw
95% CL:
>= 841 - <= 2 260
Mortality:
681 mg/kg bw: 1/51000 mg/kg bw: 2/51470 mg/kg bw: 2/5 2150 mg/kg bw: 4/5
Clinical signs:
Hypoactivity salivation, tremors ; dermal irritation: severe erythema
Body weight:
initial bw 2.44 - 2.61 kg; terminal bw not given
Gross pathology:
gross autopsy: survivors: no significant findings; decedents: hyperemia of the liver and lungs
Other findings:
no further details

Any other information on results incl. tables

RS-Freetext:
Signs of intoxication:
hypoactivity, salivation, tremor, severe erythema

681 mg/kg bw: 1/5 rabbit died between day 8 and day 14, but showed no  signs of intoxication
1000 mg/kg bw: clinical signs developed between 4-12 hours and 2/5  rabbits diedwithin the first 2 days
1470 mg/kg bw: clinical clinical signs developed between 4-12 hours, 1/5  rabbit died on day 2 and 1/5 between day 8 and day 14
2150 mg/kg bw: clinical signs developed between 0-4 hours, death of 4/5  rabbits occurred within 4 days.  

Gross autopsy revealed in survivors no significant findings; decedents  showed hyperemia of the liver and lungs

Applicant's summary and conclusion

Conclusions:
Dermal application of the testsubstance to the skin of rabbits resulted in an LD50 value of 1380 mg/kg bw
Executive summary:

Dermal application of the testsubstance to the skin of rabbits resulted in an LD50 value of 1380 mg/kg bw (Industrial Biotest Laboratories 1969)

The above results are suitable to be used for read across for Reaction mass of 2,4-xylenol and 2,5-xylenol, due to the category being based on structural similarity and comparable physicochemical properties, leading to similar (eco)toxicological properties.